Identity
- Trade Name
- SAFE-T-FILL® FDA UDI
- Generic Name
- Non-evacuated blood collection tube IVD, anticoagulant/separator FDA UDI
- Device Name
- SAFE-T-FILL® Capillary Blood Collection Microtubes, 1 mL; Prepared with Lithium Heparin and Plasma Separator Gel; Green FDA UDI
- Model / Reference
- 07 8021 FDA UDI
- Description
- SAFE-T-FILL® Capillary Blood Collection Microtubes, 1 mL; Prepared with Lithium Heparin and Plasma Separator Gel; Green FDA UDI
Identifiers
- Catalog Number
- 07 8021 FDA UDI
- Primary DI / UDI-DI
- 10643351000212 FDA UDI
- 510(k) Number
- K983517 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Non-evacuated blood collection tube IVD, anticoagulant/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 — 1 Milliliter FDA UDI
Category: Non-evacuated blood collection tube IVD, anticoagulant/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, anticoagulant/separator.
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- BD Microtainer® PST™ Tubes with LH (Lithium Heparin) - Amber — BECTON DICKINSON AND COMPANY · Class II
- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · Class II
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- S-Monovette® — Sarstedt Aktiengesellschaft & Co.KG · 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 |
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Manufacturer
- Manufacturer
- Ram Scientific
Sources (1)
- FDA UDI 44aa1e8a-f3c0-49b8-9622-2d64da554705 38 fields · synced Jun 6, 2026