FDA UDI
In Commercial Distribution
🇺🇸 United States
CAVH CATHETER
DI: 00884908029932
·
Model: MC8CAVH4
·
Medical Components, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CAVH CATHETER
- Primary DI
- 00884908029932
- Version / Model
- MC8CAVH4
- Company Name
- Medical Components, Inc.
- Labeler DUNS
- 038000253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-02-27
- Public Version
- 5
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 16202f5b-1fb3-4dd9-95ed-342713a7661a
Device Description
8F X 11.5CM STRAIGHT C.A.V.H. CATHETER SET
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
- Yes
- 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 |
|---|---|---|---|---|
| LFK | CATHETER, FEMORAL | Gastroenterology, Urology | 876.5540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15023 | Femoral artery/vein access catheter | A thin, flexible tube intended to be surgically inserted into the femoral artery or the femoral vein to provide an alternative access to a patient's vasculature, typically when other access routes are not viable or are exhausted. It may be used for continuous arteriovenous (AV) haemofiltration, the delivery of chemotherapeutic agents, or for other chronic applications to avoid repetitive injections. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50884908029937 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 00884908029932 | GS1 |
Customer Contacts
- Phone
- +1(215)256-4201
- [email protected]