Central Venous Catheter Kit 24-000251-03

GUDID 08886483508859

BIOPTIMAL INTERNATIONAL PTE. LTD.

Central venous catheterization kit, short-term
Primary Device ID08886483508859
NIH Device Record Key58eade99-6826-424b-b383-b10fae8782ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCentral Venous Catheter Kit
Version Model NumberCV-713-16T
Catalog Number24-000251-03
Company DUNS595182247
Company NameBIOPTIMAL INTERNATIONAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark cool dry places

Device Identifiers

Device Issuing AgencyDevice ID
GS108886483508859 [Primary]

FDA Product Code

FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [Central Venous Catheter Kit]

08886483508859CV-713-16T
08886483506008CV-802-20
08886483505636CV-501-16

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.