| Primary Device ID | 05707480006472 |
| NIH Device Record Key | 42c20d78-ace1-42c0-9c18-f27d57311be3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perfit Collar™ |
| Version Model Number | 000264503 |
| Catalog Number | 000264503 |
| 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 |
| 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 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 |
| 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 |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05707480006472 [Package] Contains: 05707480024599 Package: [50 Units] In Commercial Distribution |
| GS1 | 05707480024599 [Primary] |
| IQK | Orthosis, cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2022-12-08 |
| 05707480006502 | COLLAR PERFIT TALL SIZE6 |
| 05707480006496 | Collar Perfit Regular size 5 |
| 05707480006489 | Collar Perfit Short size 4 |
| 05707480006472 | Collar Perfit Neckless, size 3, cases of 50 Pcs. |
| 05707480006465 | Collar Perfit Pediatric, size 2, cases of 50 PCS |
| 05707480006458 | Collar Perfit Regular size 1 |
| 05707480006441 | Collar Perfit tall size 6 |
| 05707480006434 | Collar Perfit regular, size 5 |
| 05707480006427 | Collar Perfit short size 4 |
| 05707480006410 | Collar Perfit Neckless, size 3 |
| 05707480006403 | Collar Perfit Pediatric size 2 |
| 05707480006397 | Collar Perfit Infant size 1 |