Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Disposable vacuum tubing FDA UDI
- Device Name
- 72" Drainbag Hose - Non-Sterile FDA UDI
- Model / Reference
- CMS-945 FDA UDI
- Description
- 72" Drainbag Hose - Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849022485 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Disposable vacuum tubing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Disposable vacuum tubing
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Disposable vacuum tubing.
- ProCure — Twin Med, LLC · Class II
- Tube set for vacuum incl. filter, 30-day use — W.O.M. World of Medicine GmbH · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
- KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
- Tube set for suction, single-use — W.O.M. World of Medicine GmbH · Class II
- Vacuum Pump Tubing — Vitrolife Sweden AB · Class II
- Prabadin — Prabadin Corp · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI c5fcd999-5c5f-4ccb-820b-19a054f4c971 33 fields · synced May 30, 2026