Consulting Wallah › Device Explorer › Other devices › Non-wearable adult urine collection bag, open-ende
Device Explorer · FDA GUDID · GMDN 58921

Non-wearable adult urine collection bag, open-ended

A flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient.

US‑registered devices71in commercial distribution
Companies25labelers on GUDID
Single‑use86%of device records
Sterile70%labelled sterile
Prescription51%Rx‑only share
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Share of device records

Amsino International, Inc.1014%
Hr Pharmaceuticals Inc.811%
Urocare Products, Inc.811%
Owens & Minor Distribution, Inc.57%
Coloplast A/S46%
Sterigear, Llc46%
Flexicare Medical Limited34%
Ghc Healthcare, Inc.34%

Top labelers

CompanyDevicesShare
Amsino International, Inc.1014%
Hr Pharmaceuticals Inc.811%
Urocare Products, Inc.811%
Owens & Minor Distribution, Inc.57%
Coloplast A/S46%
Sterigear, Llc46%
Flexicare Medical Limited34%
Ghc Healthcare, Inc.34%
Dynarex Corporation34%
Coulmed Products Group Llc34%
Acosta Medical Group, Inc.23%
Tidi Products, Llc23%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Conveen StandardConveen Security+FlexicareBEDSIDE URINE COLLECTORCreate BiotechGLOBAL HEALTHCAREAcosta Uro-GardSteriGearFig Leaf®TruCathASP MEDICALENDURE INDUSTRIES"Urinary Drainage Bag Holder 11"" x 11"" (27.9 cUrinary Drainage Bag, With Anti-Reflux Valve, StAdvantage Urinary Drainage Bag, With Anti-RefluxCustom Medical Specialties, Inc.

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MMZTABLE, CYSTOMETRIC, ELECTRIC32
KNXCollector, Urine, (And Accessories) For Indwelling Catheter28
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile13
KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER13
FAQBag, Urine Collection, Leg, For External Use, Sterile11
FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE7

GMDN & GCC registration

  • GMDN code 58921 · non‑implantable
  • Single‑use 86% · sterile 70% · Rx‑only 51% · OTC 30%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 9Weight (Pound) · 8Total Volume (Milliliter) · 6Lumen/Inner Diameter (Inch) · 6Outer Diameter (Inch) · 6Length (Centimeter) · 5

Use these as the dimensions to specify in a tender line.

How many non-wearable adult urine collection bag, open-ended products are registered in the US?

71 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-wearable adult urine collection bag, open-ended", from 25 companies. The largest labeler is Amsino International, Inc. with 14% of records.

Which FDA product codes apply?

MMZ (TABLE, CYSTOMETRIC, ELECTRIC), KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), NNW (Bag, Urine Collection, Leg, For External Use, Non-Sterile), KNX (COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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