Home GUDID 00815849020931 Custom Medical Specialties, Inc.
Primary DI 00815849020931
Brand Custom Medical Specialties, Inc.
Company CUSTOM ASSEMBLIES, INC.
Model CMS-954V
Device description Vinyl Acetate Urological Drainage Bag for GE/OEC Systems - Non-Sterile
Published 2016-11-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name BWN Table And Attachments, Operating-Room
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BWN Table And Attachments, Operating-Room General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00815849020931 Package GS1 20 In Commercial Distribution 00815849020368 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00815849020931 00815849020931 815849020931 0815849020931 00815849020368 00815849020368 815849020368 0815849020368
GMDN Terms# Term, Definition table Term Definition Surgical tissue/fluid collection bag, non-sterile A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use.
Regulatory Flags# DUNS number 948904735 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00815849024021 Custom Medical Specialties, Inc. CMS-2732-R4 2023-09-14 00815849024571 Custom Medical Specialties, Inc. CMS-6314-R6 2023-09-14 00815849023369 Custom Medical Specialties, Inc. CMS-1235 2023-09-13 00815849023390 Custom Medical Specialties, Inc. CMS-1238 2023-09-13 00815849023406 PG-1000 PG-1000 2023-09-13 00815849023437 Custom Assemblies, Inc. CMS-2012-R3 2023-09-13 00815849023444 Custom Assemblies, Inc. CMS-8322-R1 2023-09-13 00815849023451 Custom Medical Specialties, Inc. CMS-5650-R2 2023-09-13 00815849023468 Custom Medical Specialties, Inc. CMS-6382 2023-09-13 00815849023475 Custom Medical Specialties, Inc. CMS-6439-C 2023-09-13 00815849023482 MPM MPM-312-R1 2023-09-13 00815849023499 Custom Medical Specialties, Inc. CMS-1911-R3 2023-09-13 00815849023505 MPM MPM-295 2023-09-13 00815849023512 Custom Medical Specialties, Inc. CMS-2450-R4 2023-09-13 00815849023529 Custom Medical Specialties, Inc. CMS-4439-R5 2023-09-13 00815849023536 Custom Medical Specialties, Inc. CMS-6803-R1 2023-09-13 00815849023543 Custom Medical Specialties, Inc. CMS-8963-R1 2023-09-13 00815849023550 Custom Medical Specialties, Inc. CMS-6415-R1 2023-09-13 00815849023567 Custom Medical Specialties, Inc. CMS-8522-R2 2023-09-13 00815849023574 Custom Medical Specialties, Inc. CMS-4028-R5 2023-09-13
Other Devices Sharing Product Codes#