FDA.reportPublic FDA data

Central Venous Catheter Kit

Primary DI
08886483508866
Brand
Central Venous Catheter Kit
Company
BIOPTIMAL INTERNATIONAL PTE. LTD.
Model
CV-713-16
Catalog number
25-000015-75
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886483508866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886483508866088864835088668886483508866

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark cool dry places

Contacts#

Phone, Email table
PhoneEmail
+6568592341ra-bpi@bioptimalg.com

Regulatory Flags#

DUNS number
595182247
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886483507470Silicone Foley CatheterFC316SDC-0001-0132026-05-04
08886483507487Silicone Foley CatheterFC314SDC-0001-0142026-05-04
08886483507494Silicone Foley CatheterFC318SDC-0001-0152026-05-04
08886483551640Thermodilution Catheter and AccessoriesTD1755HD21-000153-502026-05-20
08886483551657Thermodilution Catheter and AccessoriesTD2755NDF21-000202-452026-05-20
08886483551664Safewedge(TM) Relief Valve DeviceSafetywedge21-000212-012026-05-20
08886483500174Thermodilution Catheter and AccessoriesTD2604NXF21-000009-582026-05-04
08886483500181Thermodilution Catheter and AccessoriesTD2604NDXF21-000009-592026-05-04
08886483500372Thermodilution Catheter and AccessoriesTD2504NXF21-000046-432026-05-04
08886483500389Thermodilution Catheter and AccessoriesTD2504NDXF21-000046-442026-05-04
08886483501508Thermodilution Catheter and AccessoriesTD2704NDF21-000201-162026-05-04
08886483501515Thermodilution Catheter and AccessoriesTD2704NCXF21-000201-172026-05-04
08886483501546Thermodilution Catheter and AccessoriesTD2755NX21-000202-002026-05-04
08886483501553Thermodilution Catheter and AccessoriesTD2755NDF21-000202-012026-05-04
08886483501577Thermodilution Catheter and AccessoriesTD2755NDX21-000202-032026-05-04
08886483501584Thermodilution Catheter and AccessoriesTD2755NDPXF21-000202-042026-05-04
08886483502390BIOTRANS™ Pressure Monitoring KitsBTR4812-322-000813-232026-05-04
08886483503151BIOTRANS™ Pressure Monitoring KitsEXTENSION TUBING SET22-000895-962026-05-04
08886483503748ACCUTRANS Disposable Pressure Monitoring KitAT W/O IFU(BNS)22-000940-022026-05-04
08886483504455Embolectomy CatheterEL144023-000006-152026-05-04

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