FDA UDI
In Commercial Distribution
🇺🇸 United States
COMPACTCATH Extension Tube
DI: 10852141007847
·
Model: 1903-1832
·
COMPACTCATH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- COMPACTCATH Extension Tube
- Primary DI
- 10852141007847
- Version / Model
- 1903-1832
- Catalog Number
- 1903-1832
- Company Name
- COMPACTCATH, INC.
- Labeler DUNS
- 054765780
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2021-02-02
- Public Version
- 1
- Public Version Date
- 2021-02-10
- Public Version Status
- New
- Public Device Record Key
- 715c853d-6f1a-4b4c-bac6-61388c0d12f6
Device Description
The CompactCath extension tube is connect with CompactCath Lubricated Intermittent Urinary Catheter when needed.
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58795 | Urinary catheter/drainage bag connection facilitator | A non-sterile device intended to provide a patient or healthcare provider a means of rapid and leak-proof bag exchange during replacement of a urine bag that connects to an in situ urinary catheter. It is typically made of plastic and consists of two separate blades, each with a scissors-like handle and which terminates distally in a half-cylinder channel. The distal ends of the blades are inserted into the stretchable connector of the urine bag to form a full-cylinder channel through which the proximal end of an indwelling ureteral or urinary condom catheter is inserted to form a connection with the bag, after which the blades are removed. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00852141007840 | GS1 | ||||
| Primary | 10852141007847 | GS1 |
Customer Contacts
- Phone
- +1 (888) 933-2284
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 16 | French | |
| Length | 16 | Inch |