Identity
- Trade Name
- 1 channel pH antimony, 6.4 Fr FDA UDI
- Generic Name
- Oesophageal motility analysis system FDA UDI
- Model / Reference
- MMS-pH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717775952893 FDA UDI
- 510(k) Number
- K931963 FDA UDI
- FDA Product Code
- FFT FDA UDI
- GMDN Term
- Oesophageal motility analysis system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oesophageal motility analysis system
1 channel pH antimony, 6.4 Fr by Medical Measurement Systems B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oesophageal motility analysis system.
- EndoFLIP — Crospon, Ltd. · Class II
- 2 channel pH antimony, 15 cm spacing, 6.4 Fr — Medical Measurement Systems B.V. · Class I
- Ohmega R — Medical Measurement Systems B.V. · Class II
- Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing — Medical Measurement Systems B.V. · Class II
- 2 channel pH antimony, 10 cm spacing, 6.4 Fr — Medical Measurement Systems B.V. · Class I
- Impedance/pH, 6 imp channels, 2 pH antimony, Gastric+oes pH, Adult — Medical Measurement Systems B.V. · Class II
- 2 channel pH antimony, 21 cm spacing, 6.4 Fr — Medical Measurement Systems B.V. · Class I
- Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 Fr — Medical Measurement Systems B.V. · Class II
Cleared under the same submission
K931963 also covers:
- 1 channel pH antimony, Pediatric, 5 Fr — Medical Measurement Systems B.V.
- 2 channel pH antimony, 10 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.
- 2 channel pH antimony, 15 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.
- 2 channel pH antimony, 21 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.
- 2 channel pH antimony, 5 cm spacing, 6.4 Fr — Medical Measurement Systems B.V.
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
- Medical Measurement Systems B.V.
Sources (1)
- FDA UDI 88b547b9-c616-4cc4-9820-2a816d91f268 34 fields · synced Jun 8, 2026