Coolject 1-3cc Syringe Holder Nozzle Accessory

FDA UDI

Class U (US FDA UDI)

by Vapocoolshot, Inc

Identity

Trade Name: Coolject 1-3cc Syringe Holder Nozzle Accessory FDA UDI
Generic Name: Biopsy syringe holder, reusable FDA UDI
Device Name: Coolject 1-3cc Syringe Holder Nozzle Accessory FDA UDI
Model / Reference: VM01000-00 FDA UDI
Description: Coolject 1-3cc Syringe Holder Nozzle Accessory FDA UDI

Identifiers

Primary DI / UDI-DI: 00860006961510 FDA UDI
510(k) Number: K201248 FDA UDI
FDA Product Code: MLY FDA UDI
KZH FDA UDI
GMDN Term: Biopsy syringe holder, reusable FDA UDI

Classification

Device Class: U FDA UDI
Regulation Number: 880.6920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Biopsy syringe holder, reusable

Coolject 1-3cc Syringe Holder Nozzle Accessory by Vapocoolshot, Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biopsy syringe holder, reusable.

Belpro Medical Inc. — Belpro Medical Inc. · Class II
Belpro Medical Inc — Belpro Medical Inc. · Class II
Praxis Medical — PRAXIS MEDICAL LLC · Class II
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
Belpro Medical Inc. — Belpro Medical Inc. · Class II
CoolJect Targeted-Mist 1-3cc Nook Syringe Holder Accessory — Vapocoolshot, Inc · U
Coolject 1-3cc Syringe Holder Nozzle Accessory — Vapocoolshot, Inc · Class II

Cleared under the same submission

K201248 also covers:

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 U	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vapocoolshot, Inc

Sources (1)

FDA UDI 1a8025c4-e0fa-4e81-8890-cf8d3db8e4d6 34 fields · synced May 30, 2026