Identity
- Trade Name
- Bartels FDA UDI
- Generic Name
- Buffered isotonic saline reagent IVD FDA UDI
- Device Name
- Phosphate Buffered Saline with Mg++ and Ca++ FDA UDI
- Model / Reference
- B1029-40 FDA UDI
- Description
- Phosphate Buffered Saline with Mg++ and Ca++ FDA UDI
Identifiers
- Catalog Number
- B1029-40 FDA UDI
- Primary DI / UDI-DI
- 05391516747301 FDA UDI
- 510(k) Number
- K834136 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Buffered isotonic saline reagent IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bartels by Clark Laboratories, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI a8d2ef56-27c5-4645-9bc0-0d49d5c405a2 39 fields · synced May 30, 2026