AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™)
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™) EUDAMEDAirLife™ FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Device Name
- AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™) EUDAMEDAirLife™ Temperature monitoring EUDAMEDAirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™) FDA UDIInfant Skin Temperature Probe, Reusable FDA UDI
- Model / Reference
- AirLife™ Infant Skin Temperature Probe, Single Patient Use (Giraffe™, Panda™) EUDAMED6600-0196-700 EUDAMED6600-0628-700 EUDAMEDFDA UDI
- Description
- AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™) FDA UDIInfant Skin Temperature Probe, Reusable FDA UDI
Identifiers
- Catalog Number
- 6600-0628-700 FDA UDI
- Primary DI / UDI-DI
- 10889483587959 EUDAMEDFDA UDI10190752181236 EUDAMEDFDA UDI
- Basic UDI-DI
- 088948320041eTempProb3R8 EUDAMED0190752TDHEL1041UH EUDAMED
- Direct Marketing DI
- 10190752181236 EUDAMED
- 510(k) Number
- K121625 FDA UDI
- FDA Product Code
- FMT FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose patient temperature probe, reusable
AirLife™ Infant Skin Temperature Probe, Reusable (Lullaby™, Care Plus™) by AirLife Finland Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 088948320041eTempProb3R8 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AirLife Finland Oy
- EUDAMED SRN
- FI-MF-000001482
Sources (4)
- EUDAMED 33b7138d-acc0-4266-a817-e81b617aba5c 61 fields · synced Jul 15, 2026
- EUDAMED 6124ad97-4fb2-4846-b3ba-d02dc5551593 61 fields · synced May 18, 2026
- FDA UDI 817f6c14-8ec3-48cc-b3f8-c8b6eeb10534 37 fields · synced May 30, 2026
- FDA UDI 756254a6-7b6d-4a20-9cc4-57160f5d4ec4 36 fields · synced May 30, 2026