Reinfusion bag with Y-adapter

Primary DI
04052682000591
Brand
Reinfusion bag with Y-adapter
Company
Fresenius Kabi AG
Model
9005164
Catalog number
9005164
Device description
Reinfusion bag with Y-adapter contains a reinfusion bag and a Y-adapter to connect 2 reinfusion bags to the Packed Red Cells line.
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CACApparatus, Autotransfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960006000C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEMFresenius AG1996-07-31CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052682000591PackageGS120In Commercial Distribution
04052682000584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052682000591040526820005914052682000591
04052682000584040526820005844052682000584

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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