FDA.reportPublic FDA data

NA

Primary DI
00085412010748
Brand
NA
Company
BAXTER HEALTHCARE CORPORATION
Model
4B7878
Catalog number
4B7878
Device description
0.2% Dextrose and 0.9% Sodium Chloride Processing Solution, 2000 mL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KSWSYSTEM, PROCESSING FOR FROZEN BLOOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSWSystem, Processing For Frozen BloodHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50085412010743PackageGS16In Commercial Distribution
00085412010748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5008541201074350085412010743
00085412010748000854120107480854120107480085412010748

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell freeze/thaw systemAn assembly of devices designed for the automated processing of red blood cells received indirectly from a donor so that the cells can be safely frozen for storage in a closed, disposable set, and when needed, thawed for use. The assembly will typically add an appropriate substance (e.g., glycerol) to the blood cells to allow freezing, and facilitate the thawing process. The assembly may also wash the red blood cells to remove glycerol and plasma and extracellular components; it may also resuspend the cells in an additive solution. It will typically be comprised of pumps, a centrifuge, air detectors, a dedicated shaker, monitoring devices, disposable set, and possibly print-out facilities.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Recommended Storage - Room Temperature (25 Degrees Celsius). Avoid excessive heat. Protect from freezing.

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24
00085412017716INTERLINK/CONTINU-FLO3C00623C00622016-09-24
00085412046389CLEARLINK/DUO-VENT2C88752C88752016-09-24
00085412048499CLEARLINK/DUO-VENT2H84802H84802016-09-24
00085412048932CLEARLINK2C84012C84012016-09-24
00085412048949CLEARLINK2C84022C84022016-09-24
00085412048987CLEARLINK/CONTINU-FLO2C85462C85462016-09-24
00085412048994CLEARLINK/CONTINU-FLO2C85192C85192016-09-24
00085412049090CLEARLINK2H84012H84012016-09-24
00085412051703CLEARLINK/CONTINU-FLO2C85152C85152016-09-24
00085412068190INTERLINK2H64012H64012016-09-24
00085412069302CLEARLINK/CONTINU-FLO/CONTROL-A-FLO2C88952C88952016-09-24
00085412071107CLEARLINK/CONTINU-FLO/DUO-VENT2C85412C85412016-09-24
00085412071190CLEARLINK2C84252C84252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30812747015183ACP 215HAEMONETICS CORPORATIONKSW2017-05-02
10812747015004HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
10812747015011HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
10812747015028HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015008HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015015HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015022HAEMONETICS ACP 215 SYSTEMHAEMONETICS CORPORATIONKSW2017-02-07
30812747015800ACP 215HAEMONETICS CORPORATIONKSW2017-01-31
30812747015817ACP 215HAEMONETICS CORPORATIONKSW2017-01-31
00085412010717NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412010724NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412081908NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
00085412081915NABAXTER HEALTHCARE CORPORATIONKSW2016-09-24
50085412010712NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412010729NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412010743NABAXTER INTERNATIONAL INC.KSW2016-09-24
60085412081900NABAXTER INTERNATIONAL INC.KSW2016-09-24
50085412081910NABAXTER INTERNATIONAL INC.KSW2016-09-24
04086000101271Glycerolyte 57 SolutionFresenius Kabi AGKSW2016-09-02
04086000101288Glycerolyte 57 SolutionFresenius Kabi AGKSW2016-09-02