FDA UDI
In Commercial Distribution
🇺🇸 United States
BF
DI: 00026072023532
·
Model: 64092-AHP
·
Allied Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BF
- Primary DI
- 00026072023532
- Version / Model
- 64092-AHP
- Company Name
- Allied Medical, LLC
- Labeler DUNS
- 119066872
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-11
- Public Version
- 2
- Public Version Date
- 2025-10-13
- Public Version Status
- Update
- Public Device Record Key
- ae097775-3a34-44fa-84b9-d1c7cb2ebfde
Device Description
MASK,PED.,W/7' TUBING,50/CS
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYG | Mask, Oxygen | Anesthesiology | 868.5580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60856 | Oxygen administration kit | A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40026072023530 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00026072023532 | GS1 |