Identity
- Trade Name
- SAFE-T-FILL® FDA UDI
- Generic Name
- Capillary blood transfer tube IVD, heparin FDA UDI
- Device Name
- SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Lithium Heparin; Green FDA UDI
- Model / Reference
- 07 6101 FDA UDI
- Description
- SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Lithium Heparin; Green FDA UDI
Identifiers
- Catalog Number
- 07 6101 FDA UDI
- Primary DI / UDI-DI
- 10643351000083 FDA UDI
- 510(k) Number
- K983517 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Capillary blood transfer tube IVD, heparin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 125 Microliter FDA UDI
Category: Capillary blood transfer tube IVD, heparin
Safe-T-Fill® by Ram Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K983517 also covers:
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
- SAFE-T-FILL® — Ram Scientific
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ram Scientific
Sources (1)
- FDA UDI 0369d131-089b-4564-b807-fcea6d32ab9d 38 fields · synced Jun 8, 2026