Identity
- Trade Name
- Bariatric Long-Term Care Bed FDA UDI
- Generic Name
- Fluid/device delivery cardiac catheter FDA UDI
- Device Name
- Bariatric Long-Term Care Bed, DB200, 3 Function Standard Bed, Expands to 48" FDA UDI
- Model / Reference
- 12012 FDA UDI
- Description
- Bariatric Long-Term Care Bed, DB200, 3 Function Standard Bed, Expands to 48" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117302938 FDA UDI
- FDA Product Code
- FNL FDA UDI
- GMDN Term
- Fluid/device delivery cardiac catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Fluid/device delivery cardiac catheter
Bariatric Long-Term Care Bed by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Fluid/device delivery cardiac catheter.
- Helical Infusion Catheter — Biocardia, Inc. · Class II
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- Regard™ — ROI CPS, LLC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 261ed09f-7dff-420b-a261-2853e0855c2a 33 fields · synced Jun 8, 2026