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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
Capillary blood transfer tube IVD, sodium fluoride FDA UDI
Device Name
SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Sodium Fluoride; Gray FDA UDI
Model / Reference
07 7340 FDA UDI
Description
SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Sodium Fluoride; Gray FDA UDI

Identifiers

Catalog Number
07 7340 FDA UDI
Primary DI / UDI-DI
10643351000137 FDA UDI
510(k) Number
K983517 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Capillary blood transfer tube IVD, sodium fluoride 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 — 200 Microliter FDA UDI

Category: Capillary blood transfer tube IVD, sodium fluoride

Safe-T-Fill® by Ram Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Capillary blood transfer tube IVD, sodium fluoride.

Cleared under the same submission

K983517 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 9b2014d8-f3f4-419c-a118-95eb50cd0d1f 38 fields · synced May 30, 2026