FDA.report

Medline Industries, Inc.

Primary DI
10080196984688
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
3503
Catalog number
3503
Device description
BREATHING BAG-3L, LATEX
Published
2018-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTCBAG, RESERVOIR
PUIDrape, surgical, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196984689PackageGS130In Commercial Distribution
10080196984688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019698468940080196984689
1008019698468810080196984688

GMDN Terms

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

Contacts

PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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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

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06923980112614MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112621MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112638MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112805MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112829MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
00849296004916Welmed, Inc.WELMED INC.PUI2026-03-20
20748426264487Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
20748426264494Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
10748426264503Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
00634916019353Standard SupremeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916781373WrapPel Table CoverSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881202Circumcision Drape,STANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881226Split DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881233T-Lap Fenestrated DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
04052199810164Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810188Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04255575119459Sterile Cover KitRaguse Gesellschaft für medizinische Produkte mbHPUI2026-03-03
50198956294569CARDINAL HEALTHCardinal Health 200, LLCPUI2026-03-02
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20197344179487MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10197344179497MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
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10748426144638Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144645Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144690Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144737Medline-MicrotekMicrotek Medical LLCPUI2026-02-18