FDA.reportPublic FDA data

Medline

Primary DI
10080196292707
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS200500IR30
Catalog number
MDS200500IR30
Device description
PACK,BIOLOGICAL TEST,IR,W/30 CNTRL
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, biological sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196292708PackageGS130In Commercial Distribution
10080196292707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019629270840080196292708
1008019629270710080196292707

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument track identification tapeA non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store near sterilants or other chemical
Special Storage Condition, Specify00Keep dry
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

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
false
HCT/P
false
Kit
false
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
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
07798375773591BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037066674STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066681STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066698STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066704STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037066711STERRAD VELOCITY™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-16
10705037070718ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164677970Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678069Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678083Bionova®TERRAGENE S.A.FRC2025-08-01
07798164678090Bionova®TERRAGENE S.A.FRC2025-08-01
00850065007489SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
00850065007496SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTSHF ACQUISITION CO. LLCFRC2025-06-23
07798164674948Bionova®TERRAGENE S.A.FRC2025-04-25
07798164679103Bionova®TERRAGENE S.A.FRC2025-03-06
07798375772495BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375772501BIOTRACE™TERRAGENE S.A.FRC2025-03-06
07798375773041BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161000Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341000Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361000Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C0Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T0Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY1201017960 HealthFirst Mail-In Spore Testing Service, 12 TestMESA LABORATORIES, INC.FRC2024-12-18
07798375772877BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375773003BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772990BIOTRACE™TERRAGENE S.A.FRC2024-11-12
00686864060895Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14