FDA UDI
In Commercial Distribution
🇺🇸 United States
Perfit Collar™
DI: 05707480024513
·
Model: 000264201
·
Ambu A/S
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Perfit Collar™
- Primary DI
- 05707480024513
- Version / Model
- 000264201
- Catalog Number
- 000264201
- Company Name
- Ambu A/S
- Labeler DUNS
- 305682023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 518594f8-f571-442f-a6de-2acbffeab59e
Device Description
Collar Perfit Infant size 1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| IQK | Orthosis, cervical | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45129 | Cervical spine collar, single-use | A prefabricated (non-customized) padded device that is worn around the neck and intended to support or immobilize the cervical spine to treat deformities, fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident). This device will provide support to the head while limiting movement of the cervical vertebrae. It is available in a variety of 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 | 05707480006397 | GS1 | 20 | In Commercial Distribution | ||
| Primary | 05707480024513 | GS1 |
Customer Contacts
- Phone
- +14107686464
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Infant |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius