FDA.reportPublic FDA data

BOWIE-DICK TYPE TEST PACK pkg of 20 tests

Primary DI
M202398023
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
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
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 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079376107
Device count
20
DM exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M202398012BOWIE-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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