FDA UDI
In Commercial Distribution
🇺🇸 United States
External Catheter Segment for Hickman Pediatric Dual-Lumen CV Catheters
DI: 00801741036484
·
Model: 0601760
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- External Catheter Segment for Hickman Pediatric Dual-Lumen CV Catheters
- Primary DI
- 00801741036484
- Version / Model
- 0601760
- Catalog Number
- 0601760
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2021-03-12
- Public Version Status
- Update
- Public Device Record Key
- 159bfb3c-80f9-4ba2-aa49-fc074d874ba5
Device Description
External Catheter Segment for Hickman 7F Pediatric Dual-Lumen CV Catheters Repair Kit
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
- 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 |
|---|---|---|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65099 | Central venous catheter repair kit | A collection of devices intended to repair an in situ central venous catheter by replacing the damaged external (proximal) portion of the catheter. It includes the replacement proximal section of the catheter and devices associated with the adhesion of this section to the catheter portion remaining in situ (e.g., adhesive material, needle, syringe, sleeve); a complete central venous catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741036481 | GS1 | CA | 80 | In Commercial Distribution | |
| Primary | 00801741036484 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 7 | French |