FDA.reportPublic FDA data

BOWIE-DICK TYPE TEST PACK pkg of 20 tests

Primary DI
M202398012
Brand
BOWIE-DICK TYPE TEST PACK pkg of 20 tests
Company
Healthlink
Model
3980
Catalog number
3980
Device description
BOWIE-DICK TYPE TEST PACK pkg of 20 tests
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
M202398023PackageHIBCC4In Commercial Distribution
M202398012PrimaryHIBCC0
M202398001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-2625HLKCustomerSvc@clorox.com

Regulatory Flags#

DUNS number
079376107
Device count
20
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M202398023BOWIE-DICK TYPE TEST PACK pkg of 20 tests398039802016-09-24
M20210951MARTIN LEWIS AGAR109510952016-09-24
M20211001MODIFIED THAYER MARTIN110011002016-09-24
M20211031MUELLER HINTON110311032016-09-24
M20211041MUELLER HINTON w 5% SB110411042016-09-24
M20211061MUELLER HINTON110611062016-09-24
M20211071MUELLER HINTON w 5% SB110711072016-09-24
M20217371JEMBEC MARTIN LEWIS173717372016-09-24
M202173811JEMBEC MOD THAYER MARTIN173817382016-09-24
M2027657ML2MARTIN LEWIS G.C. SYSTEM7-657-ML7-657-ML2016-09-24
M202V8001MARTIN LEWIS G.C. SYSTEMV800V8002016-09-24
M20215021Bullseye Urine150215022016-09-24
M20234711PROSPORE AUTOCLAVE AMPULE 10/BOX347134712016-10-04

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