FDA.reportPublic FDA data

Medline

Primary DI
10888277635012
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDSPHY100LO
Catalog number
MDSPHY100LO
Device description
PAD,DEFIB,ADULT,RADIOLUCENT,PHYSIO,LO
Published
2020-10-08
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
MLNElectrode, electrocardiograph, multi-function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLNElectrode, Electrocardiograph, Multi-FunctionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080421000HEART SYNC, MODELS C-100 AND T-100Heart Sync, LLC2008-02-29MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277635012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827763501210888277635012

GMDN Terms#

Term, Definition table
TermDefinition
External defibrillator electrode padA conductive medium designed to be used between the metal contact surface of an external defibrillator electrode, of the paddle-type, and the patient's skin. A defibrillator electrode pad is available in two basic designs: 1) a thickened conductive gel or polymer layer reinforced by a non-woven material; or 2) a conductive adhesive pad with a metal contact on its outer surface. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
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
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838126275PHILIPS HeartStart SMARTPADS IIPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMLN2026-08-26
00009336010080Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
00009336010097Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010085Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
50009336010092Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2020-11-06
10888277634893MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634909MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634961MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634985MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277634992MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635005MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635029MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635036MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635050MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635067MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635074MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635081MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635098MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
10888277635104MedlineMEDLINE INDUSTRIES, INC.MLN2020-10-08
00326053105456Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105463Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105470Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
00326053105555Regard™Resource Optimization & Innovation, L.L.C.MLN2019-10-30
10326053105453Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105460Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105477Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
10326053105552Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.MLN2019-10-30
00009336009497Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009503Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17
00009336009510Heartsync by VermedGRAPHIC CONTROLS ACQUISITION CORPMLN2019-10-17