NA B125 Patient Monitor
by GE Medical Systems Information Technologies, Inc.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840682138581 | Date16 Nov 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic Name
- General-purpose multi-parameter bedside monitor
- Model / Reference
- B125 Patient Monitor
- Primary DI / UDI-DI
- 00840682138581
- FDA Product Code
- DPZ, CBQ, DQK, CCK, NHQ, MLD, FLL, CBS, DSJ, OMC, BZQ, MHX, GWQ, DSI, DSK, KRB, OLW, CCL, ORT, NHO, NHP, DQA, DXN, OLT, CBR, DRT
- GMDN Term
- General-purpose multi-parameter bedside monitor
- Device Class
- Class II
- Regulation Number
- 870.2710, 868.1500, 870.1425, 868.1400, 870.1025, 880.2910, 868.1620, 870.1100, 882.1400, 868.2375, 870.1110, 870.1915, 868.1720, 870.2700, 870.1130, 868.1700, 870.2300
- GUDID distribution status
- Not in Commercial Distribution
- MRI Safety
- MR Unsafe
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Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No