FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489361940
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ58876A
Catalog number
DYNJ58876A
Device description
PEDIATRIC EP PACK MHS
Published
2021-08-27
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
OGDCustom anesthesia tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489361941PackageGS14In Commercial Distribution
10193489361940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348936194140193489361941
1019348936194010193489361940

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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
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
10809160538975HalyardAVID MEDICAL, INC.OGD2026-09-24
10809160538579HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-22
10809160536551HalyardAVID MEDICAL, INC.OGD2026-09-18
10809160536612HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536629HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536728HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
10809160536834HalyardMEDICAL ACTION INDUSTRIES INC.OGD2026-09-18
00858965006946NAPAJUNK MEDICAL SYSTEMS, LPOGD2026-08-07
10809160528426HalyardAVID MEDICAL, INC.OGD2026-08-03
10809160527863HalyardAVID MEDICAL, INC.OGD2026-07-28
10809160522936HalyardAVID MEDICAL, INC.OGD2026-06-08
10809160523018HalyardAVID MEDICAL, INC.OGD2026-06-08
10194717116219Regard™ROI CPS, LLCOGD2022-10-05
10194717115106Regard™ROI CPS, LLCOGD2022-03-22
10194717113881Regard™ROI CPS, LLCOGD2021-11-19
10195594417451CARDINAL HEALTHCardinal Health 200, LLCOGD2021-11-05
10194717112761Regard™ROI CPS, LLCOGD2021-07-28
10194717110590Regard™ROI CPS, LLCOGD2021-05-10
10194717109730Regard™ROI CPS, LLCOGD2021-02-15
10194717109372Regard™ROI CPS, LLCOGD2021-01-14
10194717108924RegardROI CPS, LLCOGD2020-12-10
10194717107675Regard™ROI CPS, LLCOGD2020-06-25
10194717106982Regard™ROI CPS, LLCOGD2020-01-23
10194717101222Regard™ROI CPS, LLCOGD2019-12-23
10194717103042Regard™ROI CPS, LLCOGD2019-12-10
10194717102434Regard™ROI CPS, LLCOGD2019-11-01
10326053117340Regard™Resource Optimization & Innovation, L.L.C.OGD2019-09-18
10326053114363Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2018-03-28
10326053108713Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23
10326053108737Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.OGD2016-12-23