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Safe-T-Fill®

FDA UDI

Class II (US FDA UDI)

by Ram Scientific

Identity

Trade Name
SAFE-T-FILL® FDA UDI
Generic Name
Non-evacuated blood collection tube IVD, anticoagulant FDA UDI
Device Name
SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Dipotassium EDTA; Self-sealing Cap, Purple FDA UDI
Model / Reference
07 6013 FDA UDI
Description
SAFE-T-FILL® Micro Capillary Blood Collection, 125 µL; Prepared with Dipotassium EDTA; Self-sealing Cap, Purple FDA UDI

Identifiers

Catalog Number
07 6013 FDA UDI
Primary DI / UDI-DI
10643351000021 FDA UDI
510(k) Number
K981973 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Non-evacuated blood collection tube IVD, anticoagulant 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: Non-evacuated blood collection tube IVD, anticoagulant

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.

Cleared under the same submission

K981973 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ram Scientific

Sources (1)

  • FDA UDI dd347dcb-76f4-4ce2-88b0-795d23156d90 38 fields · synced May 30, 2026