Identity
- Trade Name
- Custom Medical Specialties, Inc. FDA UDI
- Generic Name
- Disposable vacuum tubing FDA UDI
- Device Name
- Fluid Control System - Non-Sterile FDA UDI
- Model / Reference
- CMS-1222 FDA UDI
- Description
- Fluid Control System - Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815849020061 FDA UDI
- FDA Product Code
- BYY FDA UDI
- GMDN Term
- Disposable vacuum tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Custom Medical Specialties, Inc. by Custom Assemblies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Custom Assemblies, Inc.
Sources (1)
- FDA UDI e2f30db9-3bb5-4835-819a-4e0cb36a267c 34 fields · synced May 30, 2026