FDA UDI
In Commercial Distribution
🇺🇸 United States
RUSCH
DI: 04026704030736
·
Model: IPN004368
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- RUSCH
- Primary DI
- 04026704030736
- Version / Model
- IPN004368
- Catalog Number
- 204800-000210
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 7
- Public Version Date
- 2021-01-25
- Public Version Status
- Update
- Public Device Record Key
- cc7d656f-a10d-42d0-80a3-15ce4663458f
Device Description
Sengstaken tube
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35416 | Oesophageal varices haemostatic tube | A flexible, hollow cylinder with an inflatable balloon(s) and aspiration port(s) intended to be non-surgically inserted into the oesophagus and stomach, through the nose or mouth, to tampon bleeding oesophageal varices. The device is also known as a Sengstaken, Blakemore, Linton or Minnesota tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24026704030730 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 04026704030736 | GS1 | ||||
| Package | 44026704030734 | GS1 | Carton | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981203 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 21 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; Keep away from sunlight