FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10884389901496
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ41223
Catalog number
DYNJ41223
Device description
CARDIAC PACING PACK
Published
2016-09-29
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
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K803086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K803086000MYOWIRE-ATEMPORARY CARDIAC PACING WIRECraig & Craig, Inc.1981-07-01LDF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389901497PackageGS15In Commercial Distribution
10884389901496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438990149740884389901497
1088438990149610884389901496

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403521174SWAN-GANZBecton, Dickinson And CompanyLDF2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyLDF2026-09-04
00885403521624SWAN-GANZBecton, Dickinson And CompanyLDF2026-09-04
08886483507166Bipolar Pacing CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.LDF2026-05-04
10801902216110ARROWTELEFLEX INCORPORATEDLDF2023-07-14
10801902198386ARROWTELEFLEX INCORPORATEDLDF2022-11-18
08718627412701MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2016-04-25
08718627411674MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411698MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411711MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411735MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411759MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411773MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411797MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411810MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411834MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411858MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411872MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411896MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411919MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411933MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411957MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411971MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627411995MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412015MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412039MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412053MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412077MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412091MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11
08718627412114MYO/Wire® Ultra-Thin Temporary Pacing Wires A & E MEDICAL CORPORATIONLDF2015-11-11