FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 14026704666116
·
Model: IPN029796
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RUSCH
- Primary DI
- 14026704666116
- Version / Model
- IPN029796
- Catalog Number
- 390060
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-20
- Public Version
- 5
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- ddce9bff-4eb1-46a0-b531-d719623e32a4
Device Description
RUSCH DRAIN BAG With Anti-Reflux Valve
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| KNX | COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | Gastroenterology, Urology | 876.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58917 | Non-wearable adult urine collection bag, closed-ended | A flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from an adult/adolescent patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704666113 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 14026704666116 | GS1 | ||||
| Previous | 14026704645715 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]