FDA UDI
In Commercial Distribution
🇺🇸 United States
Versaflex
DI: 04260167484013
·
Model: 957978
·
Given Imaging, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Versaflex
- Primary DI
- 04260167484013
- Version / Model
- 957978
- Company Name
- Given Imaging, Inc.
- Labeler DUNS
- 090073722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-29
- Public Version
- 3
- Public Version Date
- 2023-10-13
- Public Version Status
- Update
- Public Device Record Key
- fc38ace3-6eab-4e1a-942c-a3c3211a6d0e
Device Description
Disposable pH Catheter, Triple Sensor, XX and XXcm, VNITXX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FFT | Electrode, pH, stomach | Gastroenterology, Urology | 876.1400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36965 | Gastric pH ambulatory recorder | An electrically-powered device intended for 24-hour recording of the gastric acidity of the stomach through the use of a dedicated sensor. The patient is connected to and wears the device during the recording period and/or while he or she performs normal daily activities. The results will be later analysed using an appropriate device that can read and display the recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04260167481463 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 04260167484013 | GS1 |
Customer Contacts
- Phone
- +1(508)261-8000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry;Fragile