FDA.report

Medline Industries, Inc.

Primary DI
10193489867008
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYLAB1005
Catalog number
DYLAB1005
Device description
ABG KIT
Published
2021-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OFMPhlebotomy blood collection kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFMPhlebotomy Blood Collection KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40193489867009PackageGS154In Commercial Distribution
10193489867008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019348986700940193489867009
1019348986700810193489867008

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
true
Sterilization required before use
false

Other Devices From This Company

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20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
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20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956234909CARDINAL HEALTHCardinal Health 200, LLCOFM2026-01-15
20809160505349Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-12-02
50198956207637CARDINAL HEALTHCardinal Health 200, LLCOFM2025-09-29
50198956062694CARDINAL HEALTHCardinal Health 200, LLCOFM2025-05-29
20809160466602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-05-08
20809160460716Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-18
20809160460204Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2025-03-12
00860009842274Straight Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
00860009842281Butterfly Needle Phlebotomy KitLabcorp Genetics IncOFM2025-02-13
20809160432508Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-08-16
20809160424428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2024-04-30
20194717117824Regard™ROI CPS, LLCOFM2023-09-29
20194717117831Regard™ROI CPS, LLCOFM2023-09-29
20809160403324Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2023-06-23
00852714003187Aurix XLNuo Therapeutics, Inc.OFM2023-03-27
00852937003018INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14
10852937003022INNOVATE MEDICALINNOVATE MEDICAL, LLCOFM2022-11-14
50195594068224CARDINAL HEALTHCardinal Health 200, LLCOFM2021-11-05
50195594383891CARDINAL HEALTHCardinal Health 200, LLCOFM2021-10-19
20809160359270Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-09-13
20809160351861Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-06-04
50195594062864CARDINAL HEALTHCardinal Health 200, LLCOFM2021-05-13
50195594043528CARDINAL HEALTHCardinal Health 200, LLCOFM2021-05-03
50195594969729CARDINAL HEALTHCardinal Health 200, LLCOFM2021-04-07
50195594971517CARDINAL HEALTHCardinal Health 200, LLCOFM2021-04-07
50195594955715CARDINAL HEALTHCardinal Health 200, LLCOFM2021-03-31
50888439973424CARDINAL HEALTHCardinal Health 200, LLCOFM2021-01-10
20809160342036Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2021-01-06
20809160296360Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFM2020-12-02
20809160293475MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OFM2020-10-08