Central Venous Catheter Kit 25-000017-01

GUDID 08886483506008

BIOPTIMAL INTERNATIONAL PTE. LTD.

Central venous catheterization kit, short-term

• Primary Device ID: 08886483506008
• NIH Device Record Key: 3ebf54b3-6906-4de9-bd29-355b6b7e92c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Central Venous Catheter Kit
• Version Model Number: CV-802-20
• Catalog Number: 25-000017-01
• Company DUNS: 595182247
• Company Name: BIOPTIMAL INTERNATIONAL PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark cool dry places

Device Identifiers

Device Issuing Agency	Device ID
GS1	08886483506008 [Primary]

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Central Venous Catheter Kit]

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