Identity
- Trade Name
- SAFE-T-FILL® FDA UDI
- Generic Name
- Microcapillary blood collection tube IVD, no additive FDA UDI
- Device Name
- SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Untreated, Blue Marking FDA UDI
- Model / Reference
- 06 0508 FDA UDI
- Description
- SAFE-T-FILL® MicroHematocrit Capillary Tubes, 50 µL; Plastic, Untreated, Blue Marking FDA UDI
Identifiers
- Catalog Number
- 06 0508 FDA UDI
- Primary DI / UDI-DI
- 10643351000380 FDA UDI
- FDA Product Code
- GHY FDA UDI
- GMDN Term
- Microcapillary blood collection tube IVD, no additive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6400 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
Yes
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 — 50 Microliter FDA UDI
Category: Microcapillary blood collection tube IVD, no additive
Safe-T-Fill® by Ram Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microcapillary blood collection tube IVD, no additive.
- Chamber Filling Capillaries — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- TIC® 5 µL Capillary Pack (Glass) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- TIC® 5 µL Capillary Pack (Plastic) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- TIC® 20 µL Capillary Pack (Glass) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- End-to-End Volume Capillaries 20 μl — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- End-to-End Volume Capillaries 10 μl — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- TIC® 10 µL Capillary Pack (Glass) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
- TIC® 10 µL Capillary Pack (Plastic) — BIOANALYTIC GmbH, biomed. Analysentechnik · Class I
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 e7a40259-b6d3-4da3-a2f3-f27c73a6da8e 37 fields · synced Jun 8, 2026