Mini Perfit ACE™ 000281106
GUDID 05707480006526
Mini Perfit ACE,
Ambu A/S
Cervical spine collar, single-use| Primary Device ID | 05707480006526 |
| NIH Device Record Key | 5da7315b-f95e-496d-b294-f4e07c0f0e6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mini Perfit ACE™ |
| Version Model Number | 000281106 |
| Catalog Number | 000281106 |
| 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 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +1(410)768-6464 |
| 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 | 05707480006526 [Package] Contains: 05707480024650 Package: [30 Units] In Commercial Distribution |
| GS1 | 05707480024650 [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 |
Devices Manufactured by Ambu A/S
| 05707480006397 - Perfit Collar™ | 2026-01-30 Collar Perfit Infant size 1 |
| 05707480006403 - Perfit Collar™ | 2026-01-30 Collar Perfit Pediatric size 2 |
| 05707480006410 - Perfit Collar™ | 2026-01-30 Collar Perfit Neckless, size 3 |
| 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 |
Trademark Results [Mini Perfit ACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MINI PERFIT ACE 76280110 2532152 Live/Registered |
Ambu Inc. 2001-07-02 |
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