Identity
- Trade Name
- Skin Temp Probe, 5mm O.D.(Y) FDA UDI
- Generic Name
- Conventional infant incubator FDA UDI
- Model / Reference
- 60883 FDA UDI
Identifiers
- Catalog Number
- 60883 FDA UDI
- Primary DI / UDI-DI
- 04942962608831 FDA UDI
- FDA Product Code
- FMZ FDA UDI
- GMDN Term
- Conventional infant incubator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Conventional infant incubator
Skin Temp Probe, 5mm O.D.(Y) by Atom Medical Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conventional infant incubator.
- I.V. resuscitator bag holder assembly — Draeger Medical Systems, Inc. · Class I
- Babyleo TN500 — Drägerwerk AG & Co. KGaA · Class II
- Isolette Infant Incubator, Models C2000 and C2000e — Draeger Medical Systems, Inc. · Class II
- Oxygen assembly, NIST fitting, male, C2000e — Draeger Medical Systems, Inc. · Class I
- Isolette 8000 Infant Incubator — Draeger Medical Systems, Inc. · Class II
- OxyTrace Incu — Drägerwerk AG & Co. KGaA · Class II
- Giraffe Incubator Carestation — Datex-Ohmeda Inc. · Class II
- Isolette 8000 plus — Draeger Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Atom Medical Corp
Sources (1)
- FDA UDI 1c0a5765-3d8b-48f2-b30c-5b959c412922 34 fields · synced Jun 6, 2026