FDA.report

Medline

Primary DI
10080196757015
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS200450
Catalog number
MDS200450
Device description
PACK,TEST,BOWIE DICK,ADVANCED,4PK/30EA
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
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30080196757019PackageGS130In Commercial Distribution
40080196757016PackageGS1120In Commercial Distribution
10080196757015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3008019675701930080196757019
4008019675701640080196757016
1008019675701510080196757015

GMDN Terms

TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Sterilization Methods

Method

Contacts

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

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