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Immobilization Kit, with

FDA UDI

Class I (US FDA UDI)

by Ambu A/S

Identity

Trade Name
Immobilization Kit, with FDA UDI
Generic Name
Cervical spine collar, single-use FDA UDI
Device Name
Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult FDA UDI
Model / Reference
000281152 FDA UDI
Description
Ambu® Perfit ACE™ and Ambu® Head Wedge™, Adult FDA UDI

Identifiers

Catalog Number
000281152 FDA UDI
Primary DI / UDI-DI
05707480037315 FDA UDI
FDA Product Code
IQK FDA UDI
GMDN Term
Cervical spine collar, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3490 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

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 Safe FDA UDI

Category: Cervical spine collar, single-use

Immobilization Kit, with by Ambu A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical spine collar, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA UDI 75d1d380-873c-4174-b9a1-7de11d22df84 37 fields · synced Jun 1, 2026