FDA.report

Pointe Scientific, Inc. BS200 Wash Solution

Primary DI
00811727013446
Brand
Pointe Scientific, Inc. BS200 Wash Solution
Company
POINTE SCIENTIFIC, INC.
Model
12-BS200-SCS
Device description
Pointe Scientific, Inc. BS200 Wash Solution is packaged for use with the Mindray BS200 Chemical Analyzer and intended for cleaning after reagent testing. 9 x 40ml.
Published
2016-08-31
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
false

Related Records

Contact Domains

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811727013446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811727013446008117270134468117270134460811727013446

GMDN Terms

TermDefinition
Medical device-decontamination agentA non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, surgical instruments/devices, and/or laboratory analysers/instruments for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
800-445-9853techservice@medtest.com

Regulatory Flags

DUNS number
045623154
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
00811727015709Pointe Alkaline Phosphatase on the BS48014-A7516-22514-A7516-2252020-05-28
00811727015723Pointe Amylase on BS480 Analyzer14-A7564-12014-A7564-1202020-05-28
00811727015730Pointe AST on the BS480 Analyzer14-A7561-37514-A7561-3752020-05-28
00811727015754Pointe Calcium Arsenazo for BS48014-C7529-36014-C7529-3602020-05-28
00811727015778Pointe Cholesterol on BS48014-C7510-48014-C7510-4802020-05-28
00811727015792Pointe Carbon Dioxide on the BS48014-C7502-16014-C7502-1602020-05-28
00811727015839Pointe GGT on BS48014-G7571-20014-G7571-2002020-05-28
00811727015846Pointe Glucose Hexokinase for BS48014-G7517-48014-G7517-4802020-05-28
00811727015860Pointe autoHDL for the BS48014-H7545-30014-H7545-4002020-05-28
00811727015877Pointe Homocysteine for BS48014-H7575-14414-H7575-1442020-05-28
00811727015884Pointe Total Iron for the BS48014-HI904-35014-HI904-3502020-05-28
00811727015693Pointe Albumin on BS480 Analyzer14-A7502-48014-A7502-4802020-05-28
00811727018632Pointe Scientific CK-MBC7563-30C7563-302021-02-28
00811727018649Pointe Scientific CK-MBC7563-90C7563-902021-02-28
00811727014139Pointe G6PD ReagentG7583-180G7583-1802021-01-30
00811727015594Pointe Lipoprotein (a) Control SetL7597-CTLL7597-CTL2021-01-30
00811727015679Pointe G6PD ControlsG7583-CTLG7583-CTL2021-01-30
00811727015815Pointe CRP Reagent14-C7568-48014-C7568-4802021-01-30
00811727015891Pointe Lactate Reagent 14-L7596-38014-L7596-3802021-01-30
00811727015907Pointe Lactate Dehydrogenase Reagent14-L7572-20014-L7572-2002021-01-30