Perfit ACE™ 000281000

GUDID 05707480018420

Perfit Ace Adjustable 30/case

Ambu A/S

Cervical spine collar, single-use

• Primary Device ID: 05707480018420
• NIH Device Record Key: 5ac3fe41-f2cd-4691-841a-ba18dd471bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfit ACE™
• Version Model Number: 000281000
• Catalog Number: 000281000
• Company DUNS: 305682023
• Company Name: Ambu A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com
• Phone: +1(410)768-6464
• Email: Purchase_orders@ambuUSA.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480018420 [Package]; Contains: 05707480024636; Package: [30 Units]; In Commercial Distribution
GS1	05707480024636 [Primary]

FDA Product Code

• IQK: Orthosis, cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-30
• Device Publish Date: 2022-12-08

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• 05707480006427 - Perfit Collar™: 2026-01-30 Collar Perfit short size 4
• 05707480006434 - Perfit Collar™: 2026-01-30 Collar Perfit regular, size 5
• 05707480006441 - Perfit Collar™: 2026-01-30 Collar Perfit tall size 6
• 05707480006458 - Perfit Collar™: 2026-01-30 Collar Perfit Regular size 1
• 05707480006465 - Perfit Collar™: 2026-01-30 Collar Perfit Pediatric, size 2, cases of 50 PCS