No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00814247020727 | VPBB15014100 | BoogieBaby nasal aspirator – standard tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip with cover | ||
2 | 00814247020680 | VPBB15011100 | BoogieBaby nasal aspirator – preemie tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip | ||
3 | 00814247020444 | ROM-6000 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Collection Kit | |
4 | 30814247020346 | PRS-0530 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | traxi® Panniculus Retractorhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetai | ||
5 | 00814247020147 | DSD-2000 | ClearView accessory - Disposable Sound Dilator | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView | |
6 | 00814247020130 | DSD-1000 | Sound/Dilator (accessory for ClearView Uterine Manipulator) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView | ||
7 | 00814247021083 | VPBB150112100 | BoogieBaby nasal aspirator – olive tip 4.5 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch long | ||
8 | 00814247020734 | VPBB15015100 | BoogieBaby nasal aspirator – flair tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – flair tip | ||
9 | 00814247020697 | VPBB15012100 | BoogieBaby nasal aspirator – preemie tip with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – preemie tip with cover | ||
10 | 00814247020468 | ROM-QCS | ROM Plus®, Easy Strip Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Strip Quality Control | |
11 | 00814247020604 | UM900 | ClearView Uterine Manipulator, 9cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
12 | 00814247020482 | UM202 | ClearView Uterine Manipulator, long tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
13 | 00814247020475 | UM201 | ClearView Uterine Manipulator, regular tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
14 | 00814247021090 | VPBB150113100 | BoogieBaby nasal aspirator – olive tip 3.25 inch long | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 3.25 inch long | ||
15 | 00814247020857 | ROM-6025 | ROM Plus Cassette/Collection Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus, Quality Control for Fetal Membranes Rupture Tes | |
16 | 00814247020451 | ROM-QC | ROM Plus®, Quality Control for Fetal Membranes Rupture Test | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | ROM Plus® Quality Control Kit | |
17 | 00814247020284 | KDT-1000 | Koala Toco® Single-Use Tocodyamometer | HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | Koala Toco® | |
18 | 00814247020017 | UM700 | ClearView Uterine Manipulator, 7cm | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Uterine Manipulator | |
19 | 00814247020666 | VAC-6000S | Kiwi® Vacuum Delivery System ProCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® ProCup® | |
20 | 00814247021106 | VPBB150114100 | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | ||
21 | 00814247020802 | PRS-EVAL | Traxi Panniculus Retractor with Retentus Technology | CCX | Support, Patient Position | traxi® Panniculus Retractor | ||
22 | 00814247020345 | PRS-1030 | Traxi Panniculus Retractor with Retentus Technology (BMI 30-50) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor | |
23 | 00814247020659 | VAC-6000MTE | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
24 | 00814247020642 | VAC-6000MT | Kiwi® Vacuum Delivery System, OmniCup® with Traction Force Indicator | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
25 | 00814247020635 | VAC-6000ME | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
26 | 00814247020628 | VAC-6000C | Kiwi® Vacuum Delivery System, Omni-C Cup® for Cesarean Section | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® Omni-C Cup® | |
27 | 00814247020611 | UM950 | ClearView Total Uterine Manipulator, 9cm tip | LKF | Cannula, Manipulator/Injector, Uterine | 2 | ClearView Total Uterine Manipulator | |
28 | 00814247020499 | UM750 | ClearView Total Uterine Manipulator, regular tip (7cm) | LKF | Cannula, Manipulator/Injector, Uterine | ClearView Total Uterine Manipulator | ||
29 | 00814247020710 | VPBB15013100 | BoogieBaby nasal aspirator – standard tip | BYY | Tube, Aspirating, Flexible, Connecting | BoogieBaby nasal aspirator – standard tip | ||
30 | 00814247020437 | ROM-5025 | ROM Plus® Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
31 | 00814247020420 | ROM-5000 | ROM Plus® Complete Test Kit | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 1 | ROM Plus®, Fetal Membranes Rupture Test | |
32 | 00814247020406 | ROM-1025 | ROM Plus® Easy Strip Complete Kit Fetal Membranes Rupture Test | NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | ROM Plus®, Fetal Membranes Rupture Test | ||
33 | 00814247020093 | CIRC-1350 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
34 | 00814247020079 | CIRC-1300 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
35 | 00814247020055 | CIRC-1150 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | 2 | AccuCirc® | |
36 | 00814247020031 | CIRC-1100 | AccuCirc® Circumcision Device | HFX | Clamp, Circumcision | AccuCirc® | ||
37 | 00814247020000 | VAC-6000M | Kiwi® Vacuum Delivery System, OmniCup® | HDB | Extractor, Vacuum, Fetal | 2 | Kiwi® OmniCup® | |
38 | 00814247020369 | PRS-1050 | Traxi Extender (BMI>50 - used with PH-25) | CCX | Support, Patient Position | 1 | traxi® Panniculus Retractor Extender | |
39 | 00814247020277 | IPC-5090 | Cables to IUP catheters: Edan F6 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
40 | 00814247020260 | IPC-5080 | Cables to IUP catheters: Philips Avalon | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
41 | 00814247020253 | IPC-5061 | Cables to IUP catheters | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
42 | 00814247020246 | IPC-5060 | Cables to IUP catheters: Neoventa | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
43 | 00814247020239 | IPC-5050 | Cables to IUP catheters: Space Labs Medical 94000 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
44 | 00814247020222 | IPC-5018 | Cables to IUP catheters: HP8040A 40mV | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
45 | 00814247020215 | IPC-5016 | Cables to IUP catheters: Litton Air-Shields Fetascan 1400 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
46 | 00814247020208 | IPC-5014 | Cables to IUP catheters: GE Coro 115/116/118 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
47 | 00814247020192 | IPC-5012 | Cables to IUP catheters: HP8040A 5mV/1350 | HFN | Transducer, Pressure, Intrauterine | 2 | Koala® Cables | |
48 | 30814247020360 | PRS-0550 | Traxi Extender with Retentus Technology (BMI>50 - used with PH-25) | CCX | Support, Patient Position | traxi® Panniculus Retractor Extender | ||
49 | 00814247020598 | SBT-7019 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables | |
50 | 00814247020581 | SBT-7018 | Cables to FSE | HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | FSE Cables |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00757770529247 | S3628 | S3628 | ADAPTER SUCTION TUBING | Bausch + Lomb | BAUSCH & LOMB INCORPORATED |
2 | 00749756976893 | 28-3133C | 28-3133C | Bulk Tubing Custom | DeRoyal | DEROYAL INDUSTRIES, INC. |
3 | 00749756691888 | 32-1858 | NS TUBING SET | DeRoyal | DEROYAL INDUSTRIES, INC. | |
4 | 00749756579278 | 71-C720 | 71-C720 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
5 | 00749756579261 | 71-C712 | 71-C712 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
6 | 00749756579254 | 71-C710 | 71-C710 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
7 | 00749756579247 | 71-C706 | 71-C706 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
8 | 00749756579155 | 71-C620 | 71-C620 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
9 | 00749756579148 | 71-C612 | 71-C612 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
10 | 00749756579124 | 71-C610 | 71-C610 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
11 | 00749756579117 | 71-C606 | 71-C606 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
12 | 00749756579070 | 71-C520 | 71-C520 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
13 | 00749756579063 | 71-C512 | 71-C512 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
14 | 00749756579049 | 71-C510 | 71-C510 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
15 | 00749756579032 | 71-C506 | 71-C506 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
16 | 00749756578981 | 71-C501 | 71-C501 | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
17 | 00749756578967 | 71-C7100NS | 71-C7100NS | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
18 | 00749756578851 | 71-C6100NS | 71-C6100NS | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
19 | 00749756578738 | 71-C5100NS | 71-C5100NS | Tubing Suction Connector | DeRoyal | DEROYAL INDUSTRIES, INC. |
20 | 00653160229264 | NEUT98ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
21 | 00653160214321 | STLCNTUB | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
22 | 00653160210859 | STLFT316 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
23 | 00653160192766 | NEUT97ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
24 | 00653160192759 | NEUT96ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
25 | 00653160184068 | O200ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
26 | 00653160171372 | STYC3 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
27 | 00653160058277 | 61519ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
28 | 00653160047714 | ST450ST | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | ||
29 | 00385640052030 | AFTD-Y | SUMMIT MEDICAL | SUMMIT MEDICAL, INC. | ||
30 | 00385640052016 | LS7012 | SUMMIT MEDICAL | SUMMIT MEDICAL, INC. | ||
31 | 00385640052009 | LS7010 | SUMMIT MEDICAL | SUMMIT MEDICAL, INC. | ||
32 | 00026072002599 | S108-175-006RPL | 20-10-0006 | Suction Tubing | Allied Healthcare Products Inc. | ALLIED HEALTHCARE PRODUCTS, INC. |
33 | 00026072002582 | S108-175-005RPL | 20-10-0005 | Suction Tubing | Allied Healthcare Products Inc. | ALLIED HEALTHCARE PRODUCTS, INC. |
34 | B531STS162020 | STS162021217 | STS16202 | Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile | Endure | ENDURE INDUSTRIES |
35 | B49746721COLLSE0 | CollSe | Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1 Vacuum Tubing with handle and adapter; single use, sterile, flexible, 6' long, 1/2" outer diameter. | R Med Collection Set | R MEDICAL SUPPLY INC | |
36 | B461JAU117013 | JAU-1170 | INFILTRATION TUBING FOR PERISTALTIC PUMP WITH 2 SPIKES | Jac-cell USA Inc. | JAC CELL USA INC | |
37 | B461JAU11681 | JAU-1168 | Infiltration tubing for peristaltic pumps | Jac-cell USA Inc. | JAC CELL USA INC | |
38 | B461JAU116012 | JAU-1160 | Liposuction Tubing | Jac-cell USA Inc | JAC CELL USA INC | |
39 | B461JAU11591 | JAU-1159 | Aspiration Tubing | Jac-cell USA In.c | JAC CELL USA INC | |
40 | B460JA11681 | JA-1168 | Infiltration tubing for peristaltic pumps | Jac-cell Medic Inc. | 9001-2030 QUÉBEC INC | |
41 | B460JA11601 | JA-1160 | Liposuction tubing | Jac-cell Medic Inc. | 9001-2030 QUÉBEC INC | |
42 | B460JA11591 | JA-1159 | Aspiration tubing | Jac-cell Medic Inc. | 9001-2030 QUÉBEC INC | |
43 | B293HFT1100 | HFT110 | MIVI High Flow Tubing is to be used with an external source of vacuum to aspirat MIVI High Flow Tubing is to be used with an external source of vacuum to aspirate, remove, or sample body fluids. | MIVI High Flow Tubing | MIVI NEUROVASCULAR | |
44 | B090MT10100F0 | MT10-100-F | MT10-100-F | The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designe The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is a “tool,” not a “treatment.” | Control 10T Mechanical Thrombectomy System Tubing, Female Suction | ZIEN MEDICAL TECHNOLOGIES, INC. |
45 | B090MT1010030 | MT10-100-3 | MT10-100-3 | The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a c The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” | Control 10T Mechanical Thrombectomy System Tubing, 3-Pack | ZIEN MEDICAL TECHNOLOGIES, INC. |
46 | B090MT101000 | MT10-100 | MT10-100 | The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a c The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.” | Control 10T Mechanical Thrombectomy System Tubing | ZIEN MEDICAL TECHNOLOGIES, INC. |
47 | B090MT100 | MT10 | MT10 | The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.” | Control 10T Mechanical Thrombectomy Filter | ZIEN MEDICAL TECHNOLOGIES, INC. |
48 | B089B892230 | B89223 | B89223 | VITRUVIAN ASPIRATION STARTER KIT: - *FOR FIRST TIME ASPIRATOR PURCHASE ONLY*.. | N/A | BLACK & BLACK SURGICAL, INC. |
49 | B089B892200 | B89220 | B89220 | FILTER CONNECTING TUBING, 30" (CUSTOMER WILL CUT INTO PIECES AS NEEDED), 10/BOX | N/A | BLACK & BLACK SURGICAL, INC. |
50 | B089B892100 | B89210 | B89210 | 13' SOFTOUCH INFILTRATION TUBING WITH 2 BLUE MOLDED CONNECTORS, STERILE, LATEX 13' SOFTOUCH INFILTRATION TUBING WITH 2 BLUE MOLDED CONNECTORS, STERILE, LATEX FREE, 10/BOX | N/A | BLACK & BLACK SURGICAL, INC. |