Device
CV-713-16
Manufacturer
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model: CV-713-16 Catalog: 25-000015-75 DI: 08886483508866 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-04 Current Version: 2026-05-12
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 0e2e20bf-e71b-44e6-9d70-2d6944a80869
Distribution Status: In Commercial Distribution
DUNS Number: 595182247
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 08886483508866
Type: Primary
Issuing Agency: GS1
GMDN
Code: 61594
Name: Central venous catheterization kit, short-term
Definition:
A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.
FDA Product Codes
FOZ
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Environmental Conditions
Storage Handling - Storage Handling Type: Special Storage Condition, Specify
Storage Handling - Storage Handling Special Condition Text: Store in dark cool dry places