FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942507627
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKM1352A
Catalog number
DYKM1352A
Device description
BAIR PAW KIT
Published
2021-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043017000PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNSMedline Industries, Inc.2005-03-08FYA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942507627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994250762710889942507627

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393900MEDLINEBSIPIV1023BSIPIV10232026-10-01
10888277664395MEDLINEMPHUA120MPMPHUA120MP2026-10-01
20080196181893GeminiGEM1148SGEM1148S2016-10-14
20080196181954GeminiGEM2112SGEM2112S2016-10-14
20080196187307GeminiGEM5172SGEM5172S2016-10-14
20080196921208GeminiGEM2112GEM21122016-10-14
20888277655499MEDLINEMLABTP12GENMLABTP12GEN2026-10-01
10193489011265GeminiGEMTITAN54TGEMTITAN54T2021-05-26
10197344149018GeminiGEMTITAN18TCGEMTITAN18TC2025-08-14
10884389112076MEDLINE INDUSTRIES, INC.EQX7022EQX70222021-05-18
10884389121740MEDLINE INDUSTRIES, INC.EQX7044EQX70442021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196181152GeminiGEM1124SGEM1124S2016-10-14
20080196181367GeminiGEM1130SGEM1130S2016-10-14
20080196181428GeminiGEM1136SGEM1136S2016-10-14
20080196181565GeminiGEM1140SGEM1140S2016-10-14
20080196921130GeminiGEM1124GEM11242016-10-14
20080196921178GeminiGEM1145GEM11452016-10-14
20197344695314GeminiGEM5172SCGEM5172SC2024-07-15
20197344695321GeminiGEM5172TCGEM5172TC2024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918113425AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143040AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143217AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918143248AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918153704AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918155159AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918182988AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918192208AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918195544AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
16931918198286AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-09-29
04719882251900CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251924CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251948CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
04719882251962CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-07-31
09009607835207ViVi® PEEL-OFF TOGA PREMIUM XL-XXLTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835214ViVi® PEEL-OFF TOGA PREMIUM M-LTHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835221ViVi® PEEL-OFF TOGA PREMIUM XXS-STHI Total Healthcare Innovation GmbHFYA2026-07-22
09009607835238ViVi® PEEL-OFF TOGA PREMIUM 3XLTHI Total Healthcare Innovation GmbHFYA2026-07-22
10193489135909MEDLINEMEDLINE INDUSTRIES, INC.FYA2026-07-17
04719882251887CopioumedCOPIOUMED INTERNATIONAL INC.FYA2026-06-25
50885380134560CARDINAL HEALTHCardinal Health 200, LLCFYA2026-06-24
16931918123325AllesetGRI Medical & Electronic Technology Co., Ltd.FYA2026-06-04
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
20888277720050MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-11
20888277419879MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277419886MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10
20888277660905MedlineMEDLINE INDUSTRIES, INC.FYA2026-03-10