Identity
- Trade Name
- SAFE-T-FILL® FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Device Name
- SAFE-T-FILL® Micro Capillary Blood Collection, 300 µL; Prepared with Clot Activator and Serum Separator Gel; Red FDA UDI
- Model / Reference
- 07 7121 FDA UDI
- Description
- SAFE-T-FILL® Micro Capillary Blood Collection, 300 µL; Prepared with Clot Activator and Serum Separator Gel; Red FDA UDI
Identifiers
- Catalog Number
- 07 7121 FDA UDI
- Primary DI / UDI-DI
- 10643351000151 FDA UDI
- 510(k) Number
- K983517 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, clot activator/separator 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 — 300 Microliter FDA UDI
Category: Non-evacuated blood collection tube IVD, clot activator/separator
Safe-T-Fill® by Ram Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-evacuated blood collection tube IVD, clot activator/separator.
- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · Class II
- MiniCollect — Greiner Bio-One GmbH · Class II
- Emprint SX — Covidien LP · Class II
- BD Microtainer® SST™ - Amber — BECTON DICKINSON AND COMPANY · Class II
- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · Class II
- BD Microtainer® SST™ — BECTON DICKINSON AND COMPANY · Class II
- Emprint SX — Covidien LP · Class II
- Emprint SX — Covidien LP · Class II
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 848ccff7-f27c-4368-8a45-e907e0098d75 38 fields · synced Jun 7, 2026