Identity
- Trade Name
- Drager Jaundice Meter, model JM-103 FDA UDI
- Generic Name
- Transcutaneous bilirubinometer FDA UDI
- Model / Reference
- MU20606 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098000161 FDA UDI
- 510(k) Number
- K042522 FDA UDI
- FDA Product Code
- MQM FDA UDI
- GMDN Term
- Transcutaneous bilirubinometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1113 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Transcutaneous bilirubinometer
Drager Jaundice Meter, model JM-103 by Draeger Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous bilirubinometer.
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 |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI a0f68d38-4550-4085-870e-74d5923124ff 34 fields · synced Jun 9, 2026