FDA UDI
In Commercial Distribution
🇺🇸 United States
BiFLo™
DI: 10889483227275
·
Model: 0106
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BiFLo™
- Primary DI
- 10889483227275
- Version / Model
- 0106
- Catalog Number
- 0106
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-30
- Public Version
- 1
- Public Version Date
- 2026-01-07
- Public Version Status
- New
- Public Device Record Key
- c222a1d2-d337-4603-9d56-7b120acdffd6
Device Description
BiFLo™ Mask
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
- Yes
- 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 |
|---|---|---|---|---|
| 12557 | Oxygen administration face tent | A flexible, tent-like, enclosure designed to rest against the chin of the patient while remaining away from the face to provide a semi-enclosed environment of enriched oxygen (O2) to increase the patient's O2 uptake. It is connected to a high-flow O2 source and/or humidifier through wide bore tubing. It typically consists of a small rigid plastic device that is contoured around the chin and attached with head straps for stabilization. It is typically used for patients that are adverse to oxygen delivery devices such as a nasal cannula or face mask, usually due to facial surgery or trauma. This is not an O2 face mask. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483227272 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 10889483227275 | GS1 | ||||
| Previous | 00709078003714 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]