Identity
- Trade Name
- OOM101 EUDAMEDOxygen Sensor FDA UDI
- Generic Name
- Respiratory oxygen sensor FDA UDI
- Device Name
- Sauerstoffsensoren EUDAMEDOxygen Sensor OOM101 FDA UDI
- Model / Reference
- 01-00-0013 EUDAMEDOOM101 FDA UDI
- Description
- Oxygen Sensor OOM101 FDA UDI
Identifiers
- Catalog Number
- 01-00-0013 FDA UDI
- Primary DI / UDI-DI
- 04036616000345 EUDAMEDFDA UDI
- Basic UDI-DI
- 4036616OOMCK EUDAMED
- FDA Product Code
- CCL FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Respiratory oxygen sensor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1720 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Height — 30 Millimeter FDA UDIWidth — 150 Millimeter FDA UDILength — 247 Millimeter FDA UDI
Category: Respiratory oxygen sensor
Oxygen Sensor by Honeywell Healthcare Solutions GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Respiratory oxygen sensor.
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- 6600-1278-600 — City Technology Limited · Class II
- Vapotherm — Vapotherm Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Honeywell Healthcare Solutions GmbH
Sources (2)
- FDA UDI 6a0ee665-b148-4be3-a940-c01fabce45e7 37 fields · synced Jun 19, 2026
- EUDAMED 8e89501a-04e3-447a-95c2-19ed7d6f0c79 61 fields · synced Jun 19, 2026