FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
40888277555786
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
OR539K
Catalog number
OR539K
Device description
KIT, SEMI, 3000CC, TUBING 10' X 3/16"
Published
2020-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277555786PackageGS136In Commercial Distribution
10888277555785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827755578640888277555786
1088827755578510888277555785

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2) or an O2 enriched gas to a mask or nasal cannula, typically during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. 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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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

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Primary DI, Brand, Company table
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20650862199189AtriumAtrium Medical CorporationKDQ2026-02-10
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16970462546853Stone CollectorShenzhen HugeMed Medical Technical Development Co., Ltd.KDQ2026-02-10
10884389968109MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10884389968123MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143029MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
10888277143517MEDLINEMEDLINE INDUSTRIES, INC.KDQ2026-01-29
00860014577536GROWNSYOak Tech LLCKDQ2026-01-28
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00810477022272AMPLIMAMPLIM, LLCKDQ2026-01-16
00810477022289AMPLIMAMPLIM, LLCKDQ2026-01-16
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00810116023752Dornier HOOVER Access SheathDORNIER MEDTECH AMERICA, INC.KDQ2026-01-14
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