FDA UDI
In Commercial Distribution
🇺🇸 United States
Adult Large Head Strap For CPAP Mask
DI: 05055788709596
·
Model: 038-35-935U
·
FLEXICARE MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Adult Large Head Strap For CPAP Mask
- Primary DI
- 05055788709596
- Version / Model
- 038-35-935U
- Company Name
- FLEXICARE MEDICAL LIMITED
- Labeler DUNS
- 504406273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-28
- Public Version
- 1
- Public Version Date
- 2020-02-05
- Public Version Status
- New
- Public Device Record Key
- 35137e2e-6da8-4b12-bd1d-9d4f7a0f4106
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTK | Strap, Head, Gas Mask | Anesthesiology | 868.5560 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31254 | Anaesthesia mask strap, reusable | A band of material designed to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and often affixed to a special stabilizing device (e.g., with hooks) located on the gas connection port of the mask. It is typically used for anaesthesia of long duration. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05055788709596 | GS1 |