FDA.reportPublic FDA data

Waste bag 10 l

Primary DI
04052682000522
Brand
Waste bag 10 l
Company
Fresenius Kabi AG
Model
9006284
Catalog number
9006284
Device description
Waste bag, 10 Liter, is a replacement waste bag to be used with the AT1 Autotransfusion set.
Published
2015-11-10
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
GKTSeparator, Automated, Blood Cell, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKTSeparator, Automated, Blood Cell, DiagnosticHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK880007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK880007000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052682000539PackageGS15In Commercial Distribution
04052682000546PackageGS125In Commercial Distribution
04052682000522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052682000539040526820005394052682000539
04052682000546040526820005464052682000546
04052682000522040526820005224052682000522

GMDN Terms#

Term, Definition table
TermDefinition
Blood-processing autotransfusion system setA collection of devices designed to handle blood in the washing procedure performed by a blood-processing autotransfusion unit. The collection typically includes plastic tubing, filters (e.g., bacteria), connectors, and bags (e.g., red blood cell, waste); it may also include a disposable bowl for the processing solution (e.g., saline). The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous reinfused blood (autotransfusion). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31591355864wilma.hilhorst@fresenius-kabi.
+31591355864wilma.hilhorst@fresenius-kabi.com

Regulatory Flags#

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

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