FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942055203
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ0241114D
Catalog number
DYNJ0241114D
Device description
DR SAMY VEIN GRAFT EXTRA PK-LF
Published
2016-09-29
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
DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791832000VEIN GRAFT CANNULAD/P, Inc.1979-10-04DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942055203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994205520310889942055203

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA general-purpose collection of various sterile surgical instruments, dressings, and materials intended to be used to assist a range of surgical procedures across multiple clinical specialities. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Kit
true
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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479402178enableCV QuickDraw™ Plus Venous CannulaENABLECV INC.DWF2026-08-27
00824846013419NAMEDTRONIC, INC.DWF2026-08-23
00824846013501NAMEDTRONIC, INC.DWF2026-08-23
00824846012962NAMEDTRONIC, INC.DWF2026-08-14
00824846013099NAMEDTRONIC, INC.DWF2026-08-14
00824846005445NAMEDTRONIC, INC.DWF2026-07-30
00824846005469NAMEDTRONIC, INC.DWF2026-07-30
00824846005667NAMEDTRONIC, INC.DWF2026-07-30
00824846006022NAMEDTRONIC, INC.DWF2026-07-30
00824846007944NAMEDTRONIC, INC.DWF2026-07-30
00840479401096enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401119enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401133enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401157enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401171enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00840479401195enableCV Fem-Flex II™ Femoral Arterial CannulaENABLECV INC.DWF2026-07-27
00824846004721NAMEDTRONIC, INC.DWF2026-07-19
00824846004738NAMEDTRONIC, INC.DWF2026-07-19
00824846004028NAMEDTRONIC, INC.DWF2026-07-16
00824846003151NAMEDTRONIC, INC.DWF2026-07-09
00840479401416enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00840479401430enableCV EZ Glide Aortic CannulaENABLECV INC.DWF2026-07-09
00824846003472NAMEDTRONIC, INC.DWF2026-07-04
00824846003687NAMEDTRONIC, INC.DWF2026-07-04
00824846003700NAMEDTRONIC, INC.DWF2026-07-04
00824846001669NAMEDTRONIC, INC.DWF2026-06-28
00824846001843NAMEDTRONIC, INC.DWF2026-06-28
00824846001850NAMEDTRONIC, INC.DWF2026-06-28
00840479402222enableCV Percutaneous Insertion Kit-ArterialENABLECV INC.DWF2026-06-26
00824846001614NAMEDTRONIC, INC.DWF2026-06-25