FDA.reportPublic FDA data

Medline

Primary DI
40080196341383
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDSHEART1
Catalog number
MDSHEART1
Device description
DBD-SUPPORT HEART NET, 7.5" X 7.5"
Published
2021-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MWSStabilizer, heart

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWSStabilizer, HeartCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196341383PackageGS110In Commercial Distribution
10080196341382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019634138340080196341383
1008019634138210080196341382

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000446239Starfish™ EvoMEDTRONIC, INC.MWS2026-04-24
00763000446246Urchin™ EvoMEDTRONIC, INC.MWS2026-04-24
00643169668980STARFISH® EVOMEDTRONIC, INC.MWS2025-05-30
10840199536648Stabilizer ClampKOROS U.S.A., INC.MWS2024-01-31
00840199536641Stabilizer ClampKOROS U.S.A., INC.MWS2024-01-31
00192896114425Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896114432Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896114449Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2023-02-03
00192896112933Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2022-05-30
00763000543679OCTOPUS®MEDTRONIC, INC.MWS2021-07-18
00763000543686STARFISH™MEDTRONIC, INC.MWS2021-07-18
00763000543693OCTOPUS®MEDTRONIC, INC.MWS2021-07-18
00192896108509Heartline Stabilizer ArmSONTEC INSTRUMENTS, INC.MWS2021-04-08
04046955051984SHAMROCKFLEXAesculap AGMWS2021-04-05
00699753450844Titan Flex StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450851Titan Flex 360 StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
50699753450849Titan Flex StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
50699753450856Titan Flex 360 StabilizerTerumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450943Herc Flex 360 Universal Stabilizer Arm Terumo Cardiovascular Systems CorporationMWS2021-03-18
00699753450950Herc Flex Universal Stabilizer ArmTerumo Cardiovascular Systems CorporationMWS2021-03-18
10080196341382MedlineMEDLINE INDUSTRIES, INC.MWS2021-01-20
00763000284800Octopus™MEDTRONIC, INC.MWS2020-10-30
04046964828782HEARTPADAesculap AGMWS2020-08-24
04545499071194TentaclesSB-KAWASUMI LABORATORIES, INC.MWS2020-05-26
00607567500006Acrobat-i PositionerMAQUET CARDIOVASCULAR LLCMWS2020-04-27
00607567900004Acrobat SUV StabilizerMAQUET CARDIOVASCULAR LLCMWS2020-04-27
00192896100602HEARTLINE STABILIZER ARM CLAMPSONTEC INSTRUMENTS, INC.MWS2020-02-24
00607567100008Acrobat-I StabilizerMAQUET CARDIOVASCULAR LLCMWS2019-12-31
04545499071699Tentacles NEOSB-KAWASUMI LABORATORIES, INC.MWS2019-11-15
24545499071693Tentacles NEOSUMITOMO BAKELITE COMPANY LIMITEDMWS2019-11-15