FDA UDI
In Commercial Distribution
🇺🇸 United States
VYGON
DI: 00849884001013
·
Model: VYPL4S1003
·
Vygon Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VYGON
- Primary DI
- 00849884001013
- Version / Model
- VYPL4S1003
- Catalog Number
- VYPL4S1003
- Company Name
- Vygon Corporation
- Labeler DUNS
- 120818216
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-31
- Public Version
- 3
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- e269c73e-bcec-4b17-9cd8-fe96e916bdca
Device Description
4FR X 55CM SINGLE LUMEN CT PICC BASIC w/ STYLET
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 10729 | Centrally-inserted central venous catheter | A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30849884001014 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 00849884001013 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172899 | 000 |