FDA UDI
In Commercial Distribution
🇺🇸 United States
BF
DI: 00026072026212
·
Model: 61016
·
Allied Medical, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BF
- Primary DI
- 00026072026212
- Version / Model
- 61016
- 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
- ae330647-99bf-45e1-8ea3-26642dda5793
Device Description
ADAPTER,TRACH COLLAR TO
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 |
|---|---|---|---|---|
| 63861 | Gas-sampling/monitoring respiratory tubing/anaesthesia mask adaptor | A non-sterile respiratory device intended to facilitate gas sampling/monitoring by allowing an anaesthesia mask to be connected to a length of gas-sampling/monitoring respiratory tubing; the tubing (not included) is intended for subsequent connection to a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It is a small synthetic polymer device, typically with a slip/barbed connection, intended to be inserted within one of the ventilation holes of the mask. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00026072026212 | GS1 |