FDA.reportPublic FDA data

PRISMAFLEX TPE 2000 SET

Primary DI
07332414111038
Brand
PRISMAFLEX TPE 2000 SET
Company
GAMBRO INDUSTRIES
Model
114093
Catalog number
114093
Device description
The Prismaflex TPE2000 set is indicated for use only with the PrismaFlex control unit or with the PrisMax control unit (in countries where PrisMax is cleared or registered), after having selected TPE therapy. The Prismaflex TPE2000 set is intended for use in therapeutic plasma exchange, thus in diseases where removal of plasma components in indicated.
Published
2017-03-23
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
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/PlasmaUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P830063006
P830063009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P830063006GAMBRO FIBER PLASMAFILTERVantive US Healthcare, LLC1986-05-27MDP
P830063009GAMBRO FIBER PLASMAFILTERVantive US Healthcare, LLC1986-05-27MDP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37332414111039PackageGS14In Commercial Distribution
07332414111038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3733241411103937332414111039
07332414111038073324141110387332414111038

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis system filter, whole bloodA sterile device designed to separate plasma from the cellular components of whole blood during manual/automated apheresis (the separation, collection, and reinfusion of blood) for donation of blood products or apheresis therapy. It typically contains a microporous membrane (usually with pores 0.2 to 0.6 micrometers) or a hollow-fibre column; it may also be intended to filter microorganisms and/or particles. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
393020474
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332414064549PRISMAFLEX SETM601066962015-10-05
07332414064556PRISMAFLEX SETM1001066972015-10-05
07332414069315PRISMAFLEX SETHF14001071422015-10-05
07332414090005PRISMAFLEX SETM1501099902015-10-05
07332414069254PRISMAFLEX SETHF10001071402015-10-05
07332414066314DIACLEAR1068871068872016-09-24
00085412917696PRISMAFLEX SET107640US107640US2022-11-22
00085412954073PRISMAFLEX SET107636US107636US2022-11-22
00085412954103PRISMAFLEX SET107643US107643US2022-11-22
50085412917691PRISMAFLEX SET107640US107640US2022-11-22
50085412954078PRISMAFLEX SET107636US107636US2022-11-22
50085412954108PRISMAFLEX SET107643US107643US2022-11-22
37332414064540PRISMAFLEX SETM601066962015-10-05
37332414064557PRISMAFLEX SETM1001066972015-10-05
37332414069316PRISMAFLEX SETHF14001071422015-10-05
37332414090006PRISMAFLEX SETM1501099902015-10-05
37332414069255PRISMAFLEX SETHF10001071402015-10-05
37332414066315DIACLEAR1068871068872016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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