FDA.reportPublic FDA data

Medline

Primary DI
20080196323828
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS200650C
Catalog number
MDS200650C
Device description
STRIP,EMULATOR,STEAM,4",10 BX/CS
Published
2020-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20080196323828PackageGS1250In Commercial Distribution
40080196323822PackageGS12500In Commercial Distribution
10080196323821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2008019632382820080196323828
4008019632382240080196323822
1008019632382110080196323821

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, Specify00Avoid contact with an open flame or a high intensity heat source. Do not use in the presence of flammable anesthesia. Store at room temperature. Avoid excessive heat and shield from light

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
true
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
00810194401008AiraAIRA, LLCJOJ2026-02-10
00810194400896AiraAIRA, LLCJOJ2026-01-16
00810194400933AiraAIRA, LLCJOJ2026-01-16
00810194400964AiraAIRA, LLCJOJ2026-01-16
00810194401022AiraAIRA, LLCJOJ2026-01-16
20705037015921Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015945Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015969Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015914Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
50724995245523Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
07798375772570VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772860SEALSURE™TERRAGENE S.A.JOJ2025-06-03
00850064244045LarrTrue Indicating LLCJOJ2025-04-02
00850064244052CheetaTrue Indicating LLCJOJ2025-04-02
00615375013526MetriCide METREX RESEARCH, LLCJOJ2025-03-21
20686864061162Medicom SafeSealAMD Medicom IncJOJ2025-03-20
00850072625003Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625010Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625034Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625041Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625058Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00860011103424True Indicating Sterilization Indicator TapeTrue Indicating LLCJOJ2025-03-18
00850064244038True IndicatingTrue Indicating LLCJOJ2025-02-27
10724995231504CELERITYSTERIS CORPORATIONJOJ2025-01-13
07798375772532VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772754VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772808VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772846VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772907VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772969VERISURE™TERRAGENE S.A.JOJ2024-11-12