Identity
- Trade Name
- Oxygen assembly, DISS fitting, male, C2000 FDA UDI
- Generic Name
- Conventional infant incubator FDA UDI
- Model / Reference
- MU16945 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098000338 FDA UDI
- 510(k) Number
- K001242 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Conventional infant incubator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Conventional infant incubator
Oxygen assembly, DISS fitting, male, C2000 by Draeger Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conventional infant incubator.
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- Weight Monitor Unit(w/NAWI Verification) — Atom Medical Corp · Class II
- OxyTrace Incu — Drägerwerk AG & Co. KGaA · Class II
- Giraffe Incubator Carestation — Datex-Ohmeda Inc. · Class II
- Connecting Cable(W) For Dispo Skin Temp Probe — Atom Medical Corp · Class II
Cleared under the same submission
K001242 also covers:
- I.V. pole assembly, C2000e — Draeger Medical Systems, Inc.
- I.V. resuscitator bag holder assembly — Draeger Medical Systems, Inc.
- Isolette 8000 Infant Incubator — Draeger Medical Systems, Inc.
- Isolette Infant Incubator, Models C2000 and C2000e — Draeger Medical Systems, Inc.
- Oxygen assembly, DISS fitting, female C2000 — Draeger Medical Systems, Inc.
- Oxygen assembly, DISS fitting, female, C2000e — Draeger Medical Systems, Inc.
- Oxygen assembly, DISS fitting, male, C2000e — Draeger Medical Systems, Inc.
- Oxygen assembly, NIST fitting, male, C2000 — Draeger Medical Systems, Inc.
- Oxygen assembly, NIST fitting, male, C2000e — Draeger Medical Systems, Inc.
- Ventilator tubing support kit — Draeger Medical Systems, Inc.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI 28026e5f-1cfb-4a00-a182-45c9a333bc15 34 fields · synced Jun 9, 2026