Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name: MICROTEK FDA UDI
Generic Name: Cardiopulmonary resuscitation kit, single-use FDA UDI
Device Name: AUTO EXTERNAL DEFIBRILLATION, 1-EACH FDA UDI
Model / Reference: 1 FDA UDI
Description: AUTO EXTERNAL DEFIBRILLATION, 1-EACH FDA UDI

Identifiers

Primary DI / UDI-DI: 00748426120383 FDA UDI
510(k) Number: K950769 FDA UDI
FDA Product Code: CBP FDA UDI
GMDN Term: Cardiopulmonary resuscitation kit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5870 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary resuscitation kit, single-use

Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary resuscitation kit, single-use.

Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
Ever Ready First Aid — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II
Aquatic Solutions — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD
BROSELOW™ — Airlife, Inc. · Class II
Ambu® SPUR® II Adult Resuscitator — Ambu A/S · Class II

Cleared under the same submission

K950769 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 II	Pending data

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Manufacturer

Manufacturer: Microtek Medical LLC

Sources (1)

FDA UDI 66b5e92a-7386-4b78-b857-cc84a7070fb8 36 fields · synced Jun 8, 2026