FDA UDI
In Commercial Distribution
🇺🇸 United States
T-DOC 5Fr Air-Charged Single Sensor Catheter
DI: 10627825014868
·
Model: CAT595S
·
Laborie Medical Technologies Corp.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- T-DOC 5Fr Air-Charged Single Sensor Catheter
- Primary DI
- 10627825014868
- Version / Model
- CAT595S
- Company Name
- Laborie Medical Technologies Corp.
- Labeler DUNS
- 117783313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-12
- Public Version
- 2
- Public Version Date
- 2025-04-09
- Public Version Status
- Update
- Public Device Record Key
- bc6326bc-0ea7-47a8-8627-48bea467a19c
Device Description
T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | Gastroenterology, Urology | 876.1620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62243 | Urodynamic manometric catheter, electronic, single-use | A sterile flexible tube with electronic pressure sensors at the distal end intended to be inserted into the bladder via the urethra for measuring urethral/bladder pressure. Also known as a urodynamic solid-state sensor catheter, it is intended for proximal connection to appropriate equipment for urodynamic examination of a patient, and may have a lumen to fill/drain the bladder to facilitate pressure measurement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20627825014865 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10627825014868 | GS1 | ||||
| Package | 30627825014862 | GS1 | 100 | In Commercial Distribution |