FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483233221
·
Model: 6214
·
SUNMED, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10889483233221
- Version / Model
- 6214
- Catalog Number
- 6214
- Company Name
- SUNMED, LLC
- Labeler DUNS
- 069009268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-16
- Public Version
- 1
- Public Version Date
- 2025-12-24
- Public Version Status
- New
- Public Device Record Key
- 1452a3e6-3449-4cdf-87f6-d0461a60ac67
Device Description
AirLife™ Transport Set, Norman Elbow, 3 L Latex Free Breathing Bag with Cut Tail, 7' KROT with Long Straight and Threaded Nut Connectors
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 |
|---|---|---|---|---|
| BZA | Connector, Airway (Extension) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34877 | Breathing circuit bag, single-use | A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889483233221 | GS1 | ||||
| Previous | 00709078001710 | GS1 | ||||
| Package | 20889483233228 | GS1 | Box | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]