| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00612479220836 | 170-71005 | Foam Cushion ULTRA HIGH DENSITY POLYURETHANE FOAM 22" x 18" x 3" | IMP | Cushion, Wheelchair | 1 | McKesson | |
| 2 | 00612479211438 | 20-1080N | GLOVE, SURG STR LTX PF SZ8 | KGO | Surgeon'S Gloves | McKesson | ||
| 3 | 00612479191242 | 4602 | Urinary Leg Bag 750mL | FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | McKesson | |
| 4 | 10612479245249 | 16-SFOL3024 | CATHETER, FOLEY STRAIGHT TIP SILICONE 16" 24FR 15-30CC | EZL | Catheter, Retention Type, Balloon | 2 | McKesson | |
| 5 | 10612479212807 | 5052 | CONTROL SOLUTION | NBW | System, Test, Blood Glucose, Over The Counter | McKesson | ||
| 6 | 20612479189137 | 211 | Speculum, Vaginal, Non-Metal | HIB | Speculum, Vaginal, Nonmetal | McKesson. | ||
| 7 | 20612479206070 | 16-BC2134 | COLLECTION SET, BLD SAFETY LUE | FMI | Needle, Hypodermic, Single Lumen | McKeeson | ||
| 8 | 20612479107698 | 18-D50 | SHEATH, THERMOMETER ORAL DIGIT | FLL | Thermometer, Electronic, Clinical | McKeeson | ||
| 9 | 00612479232730 | 321BKMM | Scissors 5 1/2" MiniMedicut | LRW | Scissors, General, Surgical | Mckesson | ||
| 10 | 00815555024674 | 23-34 | GLOVE, LATEX CODEBLUE 12" 14 ML PF BLU, M | LYY,LZC | Latex Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 11 | 00815555024667 | 23-32 | GLOVE, LATEX CODEBLUE 12" 14 ML PF BLU, S | LYY,LZC | Latex Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 12 | 00815555024247 | 27-38 | GLOVE, NITRILE SYNTRILE PF BLU, XL | LZA,LZC | Polymer Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 13 | 00815555024223 | 27-36 | GLOVE, NITRILE SYNTRILE PF BLU, L | LZA,LZC | Polymer Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 14 | 00815555024209 | 27-34 | GLOVE, NITRILE SYNTRILE PF BLU,M | LZA,LZC | Polymer Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 15 | 00815555024124 | 97-02 | COMPRESS, INSTANT COLD PACK 5" x 7" | IMD | Pack, Hot Or Cold, Disposable | 1 | Cypress | |
| 16 | 00815555025312 | DS664Y | Disposable Stethoscope | LDE | Stethoscope, Manual | Cypress | ||
| 17 | 00815555025121 | 27-78 | PF BLACK NITRILE EXAM GLOVE, XL | LZA | Polymer Patient Examination Glove | Cypress | ||
| 18 | 00815555020461 | 84-51 | TRAY, MINOR LACERATION W/ INSTRUMENTS | KDD | Kit, Surgical Instrument, Disposable | 1 | Cypress | |
| 19 | 00612479259065 | 19-0741 | Marker, skin utility w/ labels | FZZ | Marker, Skin | 1 | Mckesson | |
| 20 | 00612479259041 | 19-0762 | Marker, skin, fine tip, w/ ruler/labels | FZZ | Marker, Skin | 1 | Mckesson | |
| 21 | 00612479258730 | 18-8576A | Overhead Isolation Gown | OEA | Non-Surgical Isolation Gown | 1 | Mckesson | |
| 22 | 00612479257610 | 30325 | FIRST AID KIT 50 Person | LRR | First Aid Kit With Drug | Mckesson | ||
| 23 | 00612479257573 | 30323 | FIRST AID KIT 25 Person | LRR | First Aid Kit With Drug | Mckesson | ||
| 24 | 00815555022663 | 23-98 | GLOVE, LATEX CYPRESS PLUS PF TEXT,XL | LYY | Latex Patient Examination Glove | Cypress | ||
| 25 | 00815555022649 | 23-96 | GLOVE, LATEX CYPRESS PLUS PF TEXT, L | LYY | Latex Patient Examination Glove | Cypress | ||
| 26 | 00815555024186 | 27-32 | GLOVE, NITRILE SYNTRILE PF BLU, S | LZA,LZC | Polymer Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 27 | 00815555024162 | 97-06 | COMPRESS, INSTANT HOT PACK 5" X 7" | IMD | Pack, Hot Or Cold, Disposable | 1 | Cypress | |
| 28 | 00815555024148 | 97-04 | COMPRESS, INSTANT COLD GEL PACK 6" x 8" | IME | Pack, Hot Or Cold, Reusable | 1 | Cypress | |
| 29 | 00815555024100 | 97-00 | COMPRESS, INSTANT COLD PACK 4" x 4" | IMD | Pack, Hot Or Cold, Disposable | 1 | Cypress | |
| 30 | 00815555024087 | 63-34 | TOURNIQUET, TEAL BLU LF 1"X18" | GAX | Tourniquet, Nonpneumatic | Cypress | ||
| 31 | 00815555023745 | 38-05 | GOWN ISOLATION PREMIUM YEL | OEA | Non-Surgical Isolation Gown | Cypress | ||
| 32 | 00815555023714 | 34-380 | LAB COAT WHT XL SPP | OEA | Non-Surgical Isolation Gown | Cypress | ||
| 33 | 00815555023684 | 34-120 | LAB COAT SM KNIT COLLAR/CUFF B | OEA | Non-Surgical Isolation Gown | Cypress | ||
| 34 | 00815555023653 | 33-140 | LAB JACKET MD KNIT COLLAR/CUFF | OEA | Non-Surgical Isolation Gown | Cypress | ||
| 35 | 00815555022625 | 23-94 | GLOVE, LATEX CYPRESS PLUS PF TEXT, M | LYY | Latex Patient Examination Glove | Cypress | ||
| 36 | 00815555022601 | 23-92 | GLOVE, LATEX CYPRESS PLUS PF TEXT, S | LYY | Latex Patient Examination Glove | Cypress | ||
| 37 | 00815555022588 | 23-90 | GLOVE, LATEX CYPRESS PLUS PF TEXT, XS | LYY | Latex Patient Examination Glove | Cypress | ||
| 38 | 00612479239593 | 43-1-243 | SCISSOR, BANDAGE LISTER SUPERC | LRW | Scissors, General, Surgical | 1 | Mckesson | |
| 39 | 00612479239562 | 43-1-100 | SPRING, REPLCMNT F/69-340 NAIL | MDM | Instrument, Manual, Surgical, General Use | 1 | Mckesson | |
| 40 | 00815555025107 | 27-76 | PF BLACK NITRILE EXAM GLOVE, L | LZA | Polymer Patient Examination Glove | Cypress | ||
| 41 | 00815555025084 | 27-74 | PF BLACK NITRILE EXAM GLOVE, M | LZA | Polymer Patient Examination Glove | Cypress | ||
| 42 | 00815555025060 | 27-72 | PF BLACK NITRILE EXAM GLOVE, S | LZA | Polymer Patient Examination Glove | Cypress | ||
| 43 | 00815555024698 | 23-38 | GLOVE, LATEX CODEBLUE 12" 14 ML PF BLU, XL | LYY,LZC | Latex Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 44 | 00815555024681 | 23-36 | GLOVE, LATEX CODEBLUE 12" 14 ML PF BLU, L | LYY,LZC | Latex Patient Examination Glove,Patient Examination Glove, Specialty | Cypress | ||
| 45 | 00612479188280 | 14-1384 | GLOVE, EXAM POLYMER LTX PF XLG | LYY | Latex Patient Examination Glove | Mckesson | ||
| 46 | 00612479188266 | 14-1383 | GLOVE, EXAM POLYMER LTX PF LG | LYY | Latex Patient Examination Glove | Mckesson | ||
| 47 | 00612479188242 | 14-1382 | GLOVE, EXAM POLYMER LTX PF MED | LYY | Latex Patient Examination Glove | Mckesson | ||
| 48 | 00612479188228 | 14-1381 | GLOVE, EXAM POLYMER LTX PF SM | LYY | Latex Patient Examination Glove | Mckesson | ||
| 49 | 00612479188204 | 14-1380 | GLOVE, EXAM POLYMER LTX PF XSM | LYY | Latex Patient Examination Glove | Mckesson | ||
| 50 | 00612479142787 | 43-1-872 | Needle Holder, Olsen-Hegar With Suture Scissor STRAIGHT SERRATED 5.5 in | FHQ | Holder, Needle, Gastroenterologic | 1 | Mckesson |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 07613336121160 | 08057524190 | 08057524190 | Creatinine plus ver.2 | ROCHE DIAGNOSTICS GMBH | |
| 2 | 07613336120965 | 08056722190 | 08056722190 | Tina-quant Albumin Gen.2 | ROCHE DIAGNOSTICS GMBH | |
| 3 | 07070060014654 | 1116974 | 1116974 | Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert | Afinion HbA1c | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| 4 | 07070060014630 | 1116972 | 1116972 | Albumin/Creatinine ration test kit. Intended use: For the determination of album Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert. | Afinion ACR | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| 5 | 07070060005744 | 1115020 | 1115020 | Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumi Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package insert. DI covers Alere Afinion ACR and Afinion ACR. | Alere Afinion™ ACR | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| 6 | 07070060005744 | 1115020 | 1115020 | Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumi Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package insert. DI covers Alere Afinion ACR and Afinion ACR. | Alere Afinion™ ACR | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| 7 | 06945040104780 | URS-11T | Urinalysis Strips | CONTEC | CONTEC MEDICAL SYSTEMS CO., LTD. | |
| 8 | 05391516743204 | O6627 | O6627 | Oxalate Urine Control - N | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 9 | 05391516743198 | O6502 | O6502 | Oxalate Urine Control - E | Trinity Biotech | TRINITY BIOTECH PUBLIC LIMITED COMPANY |
| 10 | 05055273209587 | UP8113 | TOTAL PROTEIN (UP) | RANDOX LABORATORIES LIMITED | ||
| 11 | 05055273207590 | UC5034 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of urine test strips. | URINALYSIS CONTROL - LEVEL 2 (URNAL CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 12 | 05055273207583 | UC5033 | This product is intended for in vitro diagnostic use, in the quality control of This product is intended for in vitro diagnostic use, in the quality control of urine test strips. | URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1) | RANDOX LABORATORIES LIMITED | |
| 13 | 05055273206814 | UP1570 | For the quantitative in vitro determination of total protein in urine and C.S.F. | TOTAL PROTEIN (UP) | RANDOX LABORATORIES LIMITED | |
| 14 | 05055273200546 | AU2353 | AU2353 | ASSAYED URINE CONTROL - LEVEL 3 (URN ASY CONTROL 3) | RANDOX LABORATORIES LIMITED | |
| 15 | 05055273200539 | AU2352 | AU2352 | ASSAYED URINE CONTROL - LEVEL 2 (URN ASY CONTROL 2) | RANDOX LABORATORIES LIMITED | |
| 16 | 04987486738060 | 73806 | Aution AU Control Solution is supplied in 2 different levels (High and Low) and Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.) | Aution™ AU Control Solution | ARKRAY USA, INC. | |
| 17 | 04987486009801 | 102478 | Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.) | AUTION Check Plus Controls | ARKRAY USA, INC. | |
| 18 | 04250317546593 | 0373 | 0373 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 19 | 04250317546586 | 0372 | 0372 | MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 20 | 04250317546579 | 0381 | 0381 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 21 | 04250317546562 | 0382 | 0382 | MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 22 | 04250317546531 | 0377 | 0377 | MassCheck® total Metanephrines, Urine Control Level II | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 23 | 04250317546524 | 0376 | 0376 | MassCheck® total Metanephrines, Urine Control Level I | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 24 | 04250317545138 | 0140 | 0140 | Urine Control Level II o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 25 | 04250317545121 | 0139 | 0139 | Urine Control Level I, o-Cresol, p-Cresol, Phenol in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 26 | 04250317544919 | 0163 | 0163 | Urine Control Level II, t,t-Muconic acid in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 27 | 04250317544902 | 0162 | 0162 | Urine Control Level I, t,t-Muconic acid in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 28 | 04250317543790 | 0050 | 0050 | Endocrine urine control, pathological range | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 29 | 04250317543660 | 0040 | 0040 | Endocrine urine control, normal range | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 30 | 04250317542847 | 0146 | 0146 | Urine Control Level II, Porphyrins in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 31 | 04250317542830 | 0145 | 0145 | Urine Control Level I, Porphyrins in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 32 | 04250317542779 | 0143 | 0143 | Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Ac Urine Control Level II, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 33 | 04250317542762 | 0142 | 0142 | Urine Control Level I, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Ac Urine Control Level I, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 34 | 04250317502148 | 0161 | 0161 | Urine Control Bi-Level, t,t-Muconic acid in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 35 | 04250317501271 | 0144 | 0144 | Urine Control Bi-Level, Porphyrins in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 36 | 04250317501226 | 0141 | 0141 | Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic A Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 37 | 04250317501127 | 0138 | 0138 | Urine Control Bi-Level, o-Cresol, p-Cresol, Phenol in urine | Urine Control Bi-Level | CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH |
| 38 | 04048474038811 | EIA-3881 | EIA-3881 | Micro-Albumin ELISA is a competitive test system for the quantitative measuremen Micro-Albumin ELISA is a competitive test system for the quantitative measurement of human albumin in urine. | Micro-Albumin ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 39 | 04015630936410 | 3576108160 | 3576108160 | Tinaquant Albumin | ROCHE DIAGNOSTICS GMBH | |
| 40 | 04015630926862 | 5401470190 | 5401470190 | Creatinine plus ver2 | ROCHE DIAGNOSTICS GMBH | |
| 41 | 04015630924998 | 5168589190 | 5168589190 | Creatinine plus ver2 | ROCHE DIAGNOSTICS GMBH | |
| 42 | 04015630924974 | 5168546190 | 5168546190 | Creatine Kinase | ROCHE DIAGNOSTICS GMBH | |
| 43 | 04015630923410 | 4999622190 | 4999622190 | Tinaquant Albumin | ROCHE DIAGNOSTICS GMBH | |
| 44 | 04015630920587 | 4469658190 | 4469658190 | Tinaquant Albumin Gen2 | ROCHE DIAGNOSTICS GMBH | |
| 45 | 04015630919215 | 3263991190 | 3263991190 | Creatinine plus ver2 | ROCHE DIAGNOSTICS GMBH | |
| 46 | 04015630916238 | 11875566216 | 11875566216 | Creatinine Plus | ROCHE DIAGNOSTICS GMBH | |
| 47 | 04015630916221 | 11875582216 | 11875582216 | Creatinine Plus | ROCHE DIAGNOSTICS GMBH | |
| 48 | 04015630906789 | 11775685216 | 11775685216 | Creatinine Plus | ROCHE DIAGNOSTICS GMBH | |
| 49 | 03610522007998 | 12007029 | 12007029 | qUAntify Advance Control Bilevel MiniPak (A liquid urinalysis control.) | qUAntify | BIO-RAD LABORATORIES, INC. |
| 50 | 03610522007981 | 12007028 | 12007028 | qUAntify Advance Control Bilevel (A liquid urinalysis control.) | qUAntify | BIO-RAD LABORATORIES, INC. |