Identity
- Trade Name
- MediPines Gas Exchange Monitor FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices. FDA UDI
- Model / Reference
- AGM100 FDA UDI
- Description
- The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices. FDA UDI
Identifiers
- Catalog Number
- AGM100 FDA UDI
- Primary DI / UDI-DI
- 00860001261509 FDA UDI
- 510(k) Number
- K180902 FDA UDI
- FDA Product Code
- DQA FDA UDICCL FDA UDIBZL FDA UDICCK FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI868.1720 FDA UDI868.1730 FDA UDI868.1400 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
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
Category: Multiple vital physiological parameter monitoring system, clinicalPatient monitoring system module, multiple-gasRespiration monitor
MediPines Gas Exchange Monitor by Medipines Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medipines Corporation
Sources (1)
- FDA UDI e538c3cc-d30b-4b36-bea4-ed202c037445 37 fields · synced May 30, 2026