Identity
- Trade Name
- TruCath FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- TruCath® Drainage Bag, 4,000 ml Drip Chamber, Metal-Clamp Drainage, Luer Lock Sample Port, 48" of Tubing, Bed-Sheet Clamp, Universal Hanger, Tyvek Pouch, Sterile FDA UDI
- Model / Reference
- HRDB4000 FDA UDI
- Description
- TruCath® Drainage Bag, 4,000 ml Drip Chamber, Metal-Clamp Drainage, Luer Lock Sample Port, 48" of Tubing, Bed-Sheet Clamp, Universal Hanger, Tyvek Pouch, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850045818401 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, open-ended FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
TruCath by H R Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-wearable adult urine collection bag, open-ended.
- RUSCH — TELEFLEX INCORPORATED · Class II
- AMSure® Urinary Drainage Bag — AMSINO INTERNATIONAL, INC. · Class II
- SteriGear — Sterigear, LLC · Class II
- MedPride — SHIELD-LINE, LLC · Class II
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18" — UROCARE PRODUCTS, INC. · Class I
- Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18" — UROCARE PRODUCTS, INC. · Class II
- Conveen Standard — Coloplast A/S · Class I
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" — UROCARE PRODUCTS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- H R Pharmaceuticals, Inc.
Sources (1)
- FDA UDI 76ba61d8-2217-4eaf-955c-b1b5b2178aca 34 fields · synced May 30, 2026