FDA UDI
In Commercial Distribution
🇺🇸 United States
Denver
DI: 10885403076077
·
Model: 42-2321
·
CAREFUSION 2200, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Denver
- Primary DI
- 10885403076077
- Version / Model
- 42-2321
- Catalog Number
- 42-2321
- Company Name
- CAREFUSION 2200, INC
- Labeler DUNS
- 832696038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-12
- Public Version
- 3
- Public Version Date
- 2019-11-13
- Public Version Status
- Update
- Public Device Record Key
- 0fc9edb6-5a38-4817-a630-fe6586746713
Device Description
Denver Venous Catheter, 15.5 Fr. x 60 cm
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPM | Shunt, Peritoneal | Gastroenterology, Urology | 876.5955 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13589 | Peritoneovenous shunt | A sterile, surgically implanted, subcutaneous plastic tube used to continuously drain ascites fluid from the peritoneal cavity to the jugular vein. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50885403076075 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 10885403076077 | GS1 |
Customer Contacts
- Phone
- +1(800)323-9088
- [email protected]
- Phone
- +1(800)323-9088
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 60 | Centimeter | |
| Catheter Gauge | 15.5 | French |