FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40198459134037
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ81370A
Catalog number
DYNJ81370A
Device description
ARM VASCULAR PACK-LF
Published
2024-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40198459134037PackageGS12In Commercial Distribution
10198459134036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845913403740198459134037
1019845913403610198459134036

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use 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
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450426630Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
00884450437438Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
00884450486887Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-03
10198956320123CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956328938CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956444027CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956468023CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956477230CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956486843CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956489073CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490468CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956490529CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956492721CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956496613CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956498662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
10198956500440CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-03
00884450424087Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450435403Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474549Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474556Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
00884450474563Merit Medical®Merit Medical Systems, Inc.OEZ2026-06-02
10198956311282CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956340145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956392281CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956420816CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956428089CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956429345CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956436428CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956457140CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01
10198956458796CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-06-01