FDA UDI
Not in Commercial Distribution
🇺🇸 United States
pHTip Disposable Catheter
DI: 07640172972519
·
Model: K6011-I-0731
·
Unisensor AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- pHTip Disposable Catheter
- Primary DI
- 07640172972519
- Version / Model
- K6011-I-0731
- Company Name
- Unisensor AG
- Labeler DUNS
- 483298907
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 57cfa17e-ee39-47ec-8bd5-0edf634237f5
- Distribution End Date
- 2017-09-29
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| FFX | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) | Gastroenterology, Urology | 876.1725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62246 | Gastro-oesophageal pH/impedance catheter, non-sterile | A non-sterile flexible tube with electronic sensors at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions. It is made of synthetic polymers and metal materials and is intended to be proximally connected to an appropriate external gastric pH measuring/monitoring device. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07640172972526 | GS1 | 5 | Not in Commercial Distribution | 2017-09-29 | |
| Primary | 07640172972519 | GS1 |
Customer Contacts
- Phone
- +1(603)570-2675
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6 | French |