Identity
- Trade Name
- Versaflex FDA UDI
- Generic Name
- Gastric pH ambulatory recorder FDA UDI
- Device Name
- Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R FDA UDI
- Model / Reference
- 955901 FDA UDI
- Description
- Disposable pH / Impedance Catheter, Single pH Sensor, 8 Impedance Rings, ZNIS+8R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260167483771 FDA UDI
- FDA Product Code
- FFT FDA UDI
- GMDN Term
- Gastric pH ambulatory recorder 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastric pH ambulatory recorder
Versaflex by Given Imaging , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gastric pH ambulatory recorder.
- Ohmega Sleeplab interface — Medical Measurement Systems B.V. · Class II
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
- Versaflex — Given Imaging , Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Given Imaging , Ltd.
Sources (1)
- FDA UDI bd50398f-70b2-4e79-9b83-102c581e87cf 35 fields · synced May 30, 2026