FDA.reportPublic FDA data

NA

Primary DI
00858778006355
Brand
NA
Company
FOOTPRINT MEDICAL, INC.
Model
S2UVC-436
Device description
4.0Fr Dual Lumen Silicone Umbilical Catheter
Published
2016-09-20
Public version status
Update
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
FOSCatheter, Umbilical Artery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOSCatheter, Umbilical ArteryGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091213000FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMENFootprint Medical2009-09-25FOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858778006352PackageGS15In Commercial Distribution
00858778006355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085877800635210858778006352
00858778006355008587780063558587780063550858778006355

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical catheterA very thin flexible tube designed for umbilical blood vessel access in neonates, typically for the infusion of fluids. It is used mainly in arterial catheterization procedures, but venous catheterization is also possible. It will typically have a double or triple lumen to enable additional concurrent functions such as vital sign monitoring and blood sampling (e.g., for blood gas analysis). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Contacts#

Phone, Email table
PhoneEmail
2102262600info@footprintmed.com

Regulatory Flags#

DUNS number
791238046
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858778006867N/AP1PIC1.4-STY2025-06-26
00858778006874N/AP1PIC1.9-STY2025-06-26
00858778006881N/AP2PIC1.9-STY2025-06-26
00858778006850N/APROBE-UMB2024-03-28
00858778006003NASHEATH1.42016-09-19
00858778006010NASHEATH1.92016-09-20
00859950007450NAP1FTS4.0-EN2022-09-29
00859950007467NAP1FTS5.0-EN2022-09-29
00859950007474NAP1FTS6.5-EN2022-09-29
00859950007481NAP1FTS8.0-EN2022-09-29
00859950007498NAP1FTM4.0-EN2022-09-29
00859950007504NAP1FTM5.0-EN2022-09-29
00859950007511NAP1FTM6.5-EN2022-09-29
00859950007528NAP1FTM8.0-EN2022-09-29
00859950007535NAP1FTL5.0-EN2022-09-29
00859950007542NAP1FTL6.5-EN2022-09-29
00859950007559NAP1FTL8.0-EN2022-09-29
00859950007566NAP1FTL10.0-EN2022-09-29
00859950007573NAS1FTS5.0-EN2022-09-29
00859950007580NAS1FTS6.5-EN2022-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253040203ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040210ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040289ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040326ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040333ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040340ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040395ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040401ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040201ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040218ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040287ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040324ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040331ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040348ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040393ArgyleCardinal Health 200, LLCFOS2025-01-08
50192253040409ArgyleCardinal Health 200, LLCFOS2025-01-08
10192253040296ArgyleCardinal Health 200, LLCFOS2024-10-16
10192253040357ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040294ArgyleCardinal Health 200, LLCFOS2024-10-16
50192253040355ArgyleCardinal Health 200, LLCFOS2024-10-16
10192253040388ArgyleCardinal Health 200, LLCFOS2024-09-30
50192253040386ArgyleCardinal Health 200, LLCFOS2024-09-30
10192253040371ArgyleCardinal Health 200, LLCFOS2024-08-23
50192253040379ArgyleCardinal Health 200, LLCFOS2024-08-23
10192253040364ArgyleCardinal Health 200, LLCFOS2024-07-12
50192253040362ArgyleCardinal Health 200, LLCFOS2024-07-12
10192253040302ArgyleCardinal Health 200, LLCFOS2024-06-20
50192253040300ArgyleCardinal Health 200, LLCFOS2024-06-20
10192253040319ArgyleCardinal Health 200, LLCFOS2024-06-06
50192253040317ArgyleCardinal Health 200, LLCFOS2024-06-06