FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327512508
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
013080-REV01
Catalog number
013080-REV01
Device description
STRL TAPE/PEN KIT
Published
2023-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape and bandage, adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327512508PackageGS1200In Commercial Distribution
10195327512507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532751250840195327512508
1019532751250710195327512507

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
DM exempt
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628942588907Blistape Blistape IncKGX2026-03-10
00628942588983Blistape Blistape IncKGX2026-03-10
60041260026852KrogerKROGER CO., THEKGX2026-03-09
00819143026354HealquHealqu LLCKGX2026-03-05
00819143026453HealquHealqu LLCKGX2026-03-05
00861092002644Cealogic FilmRECIBIO, INC.KGX2026-03-01
50192253049815TelfaCardinal Health 200, LLCKGX2026-02-25
50192253050088TelfaCardinal Health 200, LLCKGX2026-02-25
30197344181654CURADMEDLINE INDUSTRIES, INC.KGX2026-02-23
00819143026309HealquHealqu LLCKGX2026-02-19
05715205000360Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000407Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000438Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205000469Plum QuickFixPlum Safety ApSKGX2026-02-17
05715205100015Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205110014Plum QuickSoftPlum Safety ApSKGX2026-02-17
05715205120013Plum QuickSoftPlum Safety ApSKGX2026-02-17
00197998014789Solventum™ Transpore™Solventum US LLCKGX2026-02-15
00197998014871Solventum™ Transpore™Solventum US LLCKGX2026-02-15
00197998018916Solventum™ Transpore™Solventum US LLCKGX2026-02-15
00197998018978Solventum™ Transpore™Solventum US LLCKGX2026-02-15
00197998021985Solventum™ Medipore™Solventum US LLCKGX2026-02-15
00197998023590Solventum™ Transpore™Solventum US LLCKGX2026-02-15
00197998023750Solventum™ Medipore™Solventum US LLCKGX2026-02-15
00197998023781Solventum™ Medipore™Solventum US LLCKGX2026-02-15
00197998023811Solventum™ Medipore™Solventum US LLCKGX2026-02-15
00197998025891Solventum™ Medipore™Solventum US LLCKGX2026-02-15
00197998028052Solventum™ Micropore™Solventum US LLCKGX2026-02-15
00197998028090Solventum™ Micropore™Solventum US LLCKGX2026-02-15
00197998028410Solventum™ Micropore™Solventum US LLCKGX2026-02-15