FDA.report

Medline Industries, Inc.

Primary DI
10193489536706
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ60891
Catalog number
DYNJ60891
Device description
PK CUST ANGIOGRAPHY PK CH
Published
2019-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OEQAngiography/angioplasty kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40193489536707PackageGS15In Commercial Distribution
10193489536706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019348953670740193489536707
1019348953670610193489536706

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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50198956337969CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956339918CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956341508CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956343342CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956346541CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353211CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956353488CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956359466CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956364057CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956365399CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956373110CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956400892CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
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50198956411997CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956412154CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956413526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
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50198956415360CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956415483CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956416305CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23
50198956417937CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-03-23