Ruby Intravascular Catheter

Primary DI
00850073657003
Brand
Ruby Intravascular Catheter
Company
Venocare, Inc.
Model
VNC20130FG
Device description
The RUBY™ Intravascular Catheter consists of a radiopaque catheter having a usable length of 1.30 inches in 20-gauge size.
Published
2026-04-08
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

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244047000Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)Venocare, Inc.2025-05-23JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850073657003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850073657003008500736570038500736570030850073657003

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). This is a single-use device.

Regulatory Flags#

DUNS number
118792742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850073657021Navi Needle-free Blood Collection DeviceVNC20500FG2026-01-20
00850073657041Navi Needle-free Blood Collection DeviceVNC22500FG2026-01-20
00850073657065Navi Needle-free Blood Collection DeviceVNC24500FG2026-01-20
10850073657024Navi Needle-free Blood Collection DeviceVNC20500FG2026-01-20
00850073657027Navi Needle-free Blood Collection DeviceVNC20500FG2026-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
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