FDA UDI
In Commercial Distribution
🇺🇸 United States
Drager Jaundice Meter, model JM-103
DI: 04049098000161
·
Model: MU20606
·
DRAEGER MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Drager Jaundice Meter, model JM-103
- Primary DI
- 04049098000161
- Version / Model
- MU20606
- Company Name
- DRAEGER MEDICAL SYSTEMS, INC.
- Labeler DUNS
- 788289952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- a0f68d38-4550-4085-870e-74d5923124ff
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | Clinical Chemistry | 862.1113 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16166 | Transcutaneous bilirubinometer | A noninvasive, battery-powered, hand-held, portable instrument intended to measure transcutaneous bilirubin (TcB) levels, in order to predict total serum bilirubin (TSB) levels in a neonate. It directs a light beam into the newborn’s skin, usually on the forehead, sternum or ear, and measures the intensity of multiple wavelengths (typically 2 or more) that are reflected from the newborns subcutaneous tissue. These optical signals are processed (typically by a photocell and microprocessor) to give a TcB and/or TSB value. It is used mainly for screening hyperbilirubinemia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049098000161 | GS1 |
Customer Contacts
- Phone
- +18004372437
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042522 | 000 |