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Hands Free Syringe

FDA UDI

Class II (US FDA UDI)

by Bluefin Medical Llc

Identity

Trade Name
Hands Free Syringe FDA UDI
Generic Name
Pain management medication delivery system FDA UDI
Device Name
Hands Free Syringe single-use sterile syringe FDA UDI
Model / Reference
HFS-SYR FDA UDI
Description
Hands Free Syringe single-use sterile syringe FDA UDI

Identifiers

Catalog Number
412073-001 FDA UDI
Primary DI / UDI-DI
00850316008005 FDA UDI
510(k) Number
K153599 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Pain management medication delivery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pain management medication delivery system

Hands Free Syringe by Bluefin Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pain management medication delivery system.

Cleared under the same submission

K153599 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bluefin Medical Llc

Sources (1)

  • FDA UDI 735b6eba-8f61-421a-8e6d-b1ebe665565e 35 fields · synced May 30, 2026