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 | 00850108006547 | RTG-03009 | RTG-03009 | RespVac Suction Connecting Tubing Kit Non-Sterile, 3/16" x 6' tube and 3/16" x 18" tube | RespVac™ | CUTTING EDGE HC BRANDS LLC |
2 | 00850108006530 | RTG-03008 | RTG-03008 | RespVac Suction Connecting Tubing 3/16" X 18" Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
3 | 00850108006523 | RTG-03007 | RTG-03007 | RespVac Suction Connecting Tubing 3/16" X 20' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
4 | 00850108006516 | RTG-03006 | RTG-03006 | RespVac Suction Connecting Tubing 3/16" X 12' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
5 | 00850108006509 | RTG-03005 | RTG-03005 | RespVac Suction Connecting Tubing 3/16" X 10' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
6 | 00850108006493 | RTG-03004 | RTG-03004 | RespVac Suction Connecting Tubing 3/16" X 6' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
7 | 00850108006486 | RTG-03003 | RTG-03003 | RespVac Suction Connecting Tubing 1/4" X 20' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
8 | 00850108006479 | RTG-03002 | RTG-03002 | RespVac Suction Connecting Tubing 1/4" X 12' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
9 | 00850108006462 | RTG-03001 | RTG-03001 | RespVac Suction Connecting Tubing 1/4" X 10' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
10 | 00850108006455 | RTG-03000 | RTG-03000 | RespVac Suction Connecting Tubing 1/4" X 6' Sterile | RespVac™ | CUTTING EDGE HC BRANDS LLC |
11 | 00849233012943 | 157 | 157 | 6' X 3/16" ID Suction Tubing | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
12 | 00849233012936 | 155 | 155 | 10' X 1/4" ID Suction Tubing | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
13 | 00849233012929 | 154 | 154 | 6' X 1/4" ID Suction Tubing | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
14 | 00849233012912 | 153 | 153 | 6' X 3/8" ID Uterine Aspirating Tubing with Handle and Adapter | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
15 | 00849233012905 | 151 | 151 | 6' X 1/2" ID Uterine Aspirating Tubing with Handle without Adapter | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
16 | 00849233012899 | 150 | 150 | 6' X 1/2" ID Uterine Aspirating Tubing with Handle and Adaptor | Busse Hospital Disposables | ROBERT BUSSE & CO., INC. |
17 | 00840329811679 | B89223 | B89223 | VITRUVIAN ASPIRATION STARTER KIT: - *FOR FIRST TIME ASPIRATOR PURCHASE ONLY*.. | N/A | BLACK & BLACK SURGICAL, INC. |
18 | 00840329800383 | B89168 | B89168 | 6'(180CM) SILCONE TUBING.. | N/A | BLACK & BLACK SURGICAL, INC. |
19 | 00840329800314 | B89121 | B89121 | SILICONE SUCTION TUBE WITH COUPLING PIECE, 6' | N/A | BLACK & BLACK SURGICAL, INC. |
20 | 00840329800307 | B89120 | B89120 | COUPLING PIECE FOR CANISTER LID 89119 | N/A | BLACK & BLACK SURGICAL, INC. |
21 | 00840329800178 | B78622 | B78622 | EXTENSION TUBING WITH CONNECTOR FOR 78610 | N/A | BLACK & BLACK SURGICAL, INC. |
22 | 00840117313651 | 32105 | Resp-O2 Suction Connecting Tubing Non-Conductive 3/16" x 10' Tube with male connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
23 | 00840117309395 | 32112 | Resp-O2 Suction Connecting Tubing Non-Conductive 9/32" x 6' tube with male connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
24 | 00840117309371 | 32111 | Resp-O2 Suction Connecting Tubing Non-Conductive 1/4" x 20' Tube with Male Connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
25 | 00840117309296 | 32107 | Resp-O2 Suction Connecting Tubing Non-Conductive 3/16" x 20' Tube with Male Connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
26 | 00840117309272 | 32106 | Resp-O2 Suction Connecting Tubing Non0Conductive 3/16" x 12' Tube with male connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
27 | 00840117309258 | 32104 | Resp-O2 Suction Connecting Tubing Non-Conductive 3/16" x 6' Tube with Male Connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
28 | 00840117309234 | 32103 | Resp-O2 Suction Connecting Tubing Non-Conductive 3/16" x 18" tube with Male Connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
29 | 00840117309210 | 32100 | Resp-O2 Suction Tubing Combo Pack 3/16"x6' and 3/16" x 18" with male connector | Resp-O2 Suction Connecting Tube | DYNAREX CORPORATION | |
30 | 00816777026705 | MVTK110 | MVTK110 | Tubing Kit - Stroke | Tubing Kit - Stroke | MICROVENTION INC. |
31 | 00816777025906 | MVSK60 | MVSK60 | Syringe Kit - Stroke | Syringe Kit - Stroke | MICROVENTION INC. |
32 | 00816744029043 | NN-9004 | Aspiration Line | NICO Myriad | NICO CORPORATION | |
33 | 00815849023376 | CMS-104 | 20' Tubing with MF LL - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
34 | 00815849023086 | CMS-171 | Instillation (BCG) Kit - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
35 | 00815849022928 | CMS-170 | Urology Tubing Set - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
36 | 00815849021419 | CMS-108 | 30' Tubing with M/F Luer-Lock - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
37 | 00815849021310 | CMS-1236 | 72" Flush Kit - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
38 | 00815849021297 | CMS-1224 | Stopcock Controlled Flush/Contract and Disposal System - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
39 | 00815849021105 | CMS-1203 | Custom Flush and Disposal System - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
40 | 00815849021082 | CMS-1202 | Standard Flush and Disposal System - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
41 | 00815849021068 | CMS-1201 | Standard Flush/Contrast and Disposal System - Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
42 | 00815849020061 | CMS-1222 | Fluid Control System - Non-Sterile | Custom Medical Specialties, Inc. | CUSTOM ASSEMBLIES, INC. | |
43 | 00815277023337 | 16108 | Curaplex Yankauer without Vent 20ea/pk | Curaplex | BOUND TREE MEDICAL, LLC | |
44 | 00815277023313 | 16107 | Curaplex Yankauer with Vent 20ea/pk | Curaplex | BOUND TREE MEDICAL, LLC | |
45 | 00815277023290 | 16106 | Curaplex Suction Tubing 1/4 in x 6 ft 20ea/pk | Curaplex | BOUND TREE MEDICAL, LLC | |
46 | 00815277023276 | 16105 | Curaplex Yankauer Suction Tubing w/Control Vent, 6 ft Tubing 20ea/bx | Curaplex | BOUND TREE MEDICAL, LLC | |
47 | 00814247021113 | VPBB150115100 | BoogieBaby nasal aspirator – olive tip 3.25 inch with cover | BoogieBaby nasal aspirator – olive tip 3.25 inch with cover | CLINICAL INNOVATIONS, LLC | |
48 | 00814247021106 | VPBB150114100 | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | BoogieBaby nasal aspirator – olive tip 4.5 inch with cover | CLINICAL INNOVATIONS, LLC | |
49 | 00814247021090 | VPBB150113100 | BoogieBaby nasal aspirator – olive tip 3.25 inch long | BoogieBaby nasal aspirator – olive tip 3.25 inch long | CLINICAL INNOVATIONS, LLC | |
50 | 00814247021083 | VPBB150112100 | BoogieBaby nasal aspirator – olive tip 4.5 inch long | BoogieBaby nasal aspirator – olive tip 4.5 inch long | CLINICAL INNOVATIONS, LLC |