BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Military Head Wedge™

DI: 05707480024490 · Model: 000264064 · Ambu A/S

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

10

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Basic Information

Brand Name: Military Head Wedge™
Primary DI: 05707480024490
Version / Model: 000264064
Catalog Number: 000264064
Company Name: Ambu A/S
Labeler DUNS: 305682023
Distribution Status: In Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2022-12-08
Public Version: 4
Public Version Date: 2026-02-09
Public Version Status: Update
Public Device Record Key: 1dca476c-e340-4594-8ccd-611d94a50463

Device Description

Cervical Immobilization Device

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Safe
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCX	SUPPORT, PATIENT POSITION	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45259	Extrication collar, single-use	A rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05707480006380	GS1		10	In Commercial Distribution
Primary	05707480024490	GS1
Unit of Use	05707480024506	GS1

Customer Contacts

Phone: +1(410)768-6464
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -5 – 40 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: -5 – 40 Degrees Celsius