Volumat™ Line

Primary DI
04250273733860
Brand
Volumat™ Line
Company
Fresenius Kabi AG
Model
VL SP40-11
Catalog number
M46445475
Device description
For use with Agilia VP MC pumps / Volumat MC Agilia pump or gravity only.
Published
2018-08-28
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
FRNPump, Infusion
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121613000
K220301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121613000AGILIA INFUSION SYSTEMFresenius Kabi AG2013-05-01FRN
K220301000Volumat LineFresenius Kabi2023-06-02FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250273733877PackageGS130In Commercial Distribution
04250273733860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250273733877042502737338774250273733877
04250273733860042502737338604250273733860

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight. Store at controlled room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+496621168400heinrich.martens@fresenius-kab
+496621168400heinrich.martens@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
No natural rubber latex
true

Other Devices From This Company#

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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
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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
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03

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