FDA.reportPublic FDA data

Glycerolyte 57 Solution

Primary DI
04086000101271
Brand
Glycerolyte 57 Solution
Company
Fresenius Kabi AG
Model
4A7831
Catalog number
4A7831
Device description
400 ML. Cryopreservative processing solution for manufacture of Red Blood Cells, Frozen. Not for intravenous infusion.
Published
2016-09-02
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

Product Codes#

Code, Name table
CodeName
KSWSystem, Processing For Frozen Blood

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1802540

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802540

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14086000101278PackageGS112In Commercial Distribution
04086000101271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1408600010127814086000101278
04086000101271040860001012714086000101271

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Prior to use, the temperature of the product should be brought to equilibrium with the working environment typically ranging from 20 to 25°C.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315654579
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137013012Aurora Xi611259237861125923782026-08-08
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09

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
00085412010748NABAXTER 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
04086000101288Glycerolyte 57 SolutionFresenius Kabi AGKSW2016-09-02