FDA UDI
Not in Commercial Distribution
🇺🇸 United States
N/A
DI: 10190752135673
·
Model: M1091316VS
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 10190752135673
- Version / Model
- M1091316VS
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-15
- Public Version
- 8
- Public Version Date
- 2026-01-30
- Public Version Status
- Update
- Public Device Record Key
- 6c75a748-ef6a-4eef-b90d-8a077d3ea46d
- Distribution End Date
- 2026-01-29
Device Description
T-Piece Neonatal Patient Circuit Kit, Disposable
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37706 | Ventilator breathing circuit, single-use | An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20190752135670 | GS1 | 10 | Not in Commercial Distribution | 2026-01-29 | |
| Primary | 10190752135673 | GS1 |
Customer Contacts
- Phone
- 1-833-327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093913 | 000 |