FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10889942352371
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKA1202
Catalog number
DYKA1202
Device description
ADMIT KIT HILTON HEAD HOSPITAL
Published
2016-11-07
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
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001872000I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411Codan US Corp.2000-09-07FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889942352371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088994235237110889942352371

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
Expiration date on label
true
No natural rubber latex
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
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)Dynarex CorporationFPA2026-06-30
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23