FDA UDI
In Commercial Distribution
🇺🇸 United States
AirLife™
DI: 10889483577387
·
Model: 2075796-001
·
AirLife Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AirLife™
- Primary DI
- 10889483577387
- Version / Model
- 2075796-001
- Catalog Number
- 2075796-001
- Company Name
- AirLife Finland Oy
- Labeler DUNS
- 368457563
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-26
- Public Version
- 1
- Public Version Date
- 2025-04-03
- Public Version Status
- New
- Public Device Record Key
- e7669f3f-a35b-4b67-8df4-f934675a7aa2
Device Description
AirLife™ Infant Skin Temperature Probe, Reusable (Giraffe™, Panda™)
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FMZ | Incubator, Neonatal | General Hospital | 880.5400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37340 | General-purpose patient temperature probe, reusable | A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889483577387 | GS1 | ||||
| Previous | 10190752179622 | GS1 |
Customer Contacts
- Phone
- (800)433-2797
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius