FDA.reportPublic FDA data

PRISMAFLO® II S

Primary DI
04260114149897
Brand
PRISMAFLO® II S
Company
Stihler Electronic GmbH
Model
PF2300NA
Catalog number
PF2300NA
Device description
Blood warmer
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KOCACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOCAccessories, Blood Circuit, HemodialysisGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082758000PRISMAFLO IIStihler Electronic GmbH2008-12-19KOC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260114149897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260114149897042601141498974260114149897

GMDN Terms#

Term, Definition table
TermDefinition
Conduction blood/fluid warmerA mains electricity (AC-powered) device, which may include rechargeable batteries, designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the conduction of heat. The device usually includes a surface heat exchanger (e.g., heated dry plate) for the conduction of heat to the infusion blood/fluid via a disposable set (e.g., tubing or pouch); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317742377
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260114140221ASTOPAD®COV070-NACOV070-NA2020-10-08
04260114140238ASTOPAD®COV105-NACOV105-NA2020-10-08
04260114140245ASTOPAD®COV150-NACOV150-NA2020-10-08
04260114140252ASTOPAD®COV155-NACOV155-NA2020-10-08
04260114140269ASTOPAD®COV180-NACOV180-NA2020-10-08
04260114140030ASTOPAD®DUO310-NADUO310-NA2020-10-07
04260114141433ASTOTUBE®M77455502M774555022024-08-16
04260114141440ASTOTUBE®M774600022024-08-16
04260114141389ASTOTUBE®M77455502M774555022024-08-16
04260114141396ASTOTUBE®M774600022024-08-16
04260114140610ASTOTUBE®IFT40410IFT404102016-09-07
04260114140627ASTOTUBE®IFT30350IFT303502016-09-07
04260114140634ASTOTUBE®IFT30460IFT304602016-09-07
04260114140641ASTOTUBE®IFT30410IFT304102016-08-11
04260114140214ASTODIADIA1002023-07-18
04260114140375ASTOTHERM® PLUSAP220EUAP220EU2016-08-31
04260114140382ASTOTHERM® PLUSAP220SEUAP220SEU2016-08-31
04260114140399ASTOTHERM® PLUSAP260EUAP260EU2016-08-31
04260114140405ASTOTHERM® PLUSAP260SEUAP260SEU2016-08-31
04260114140443ASTOLINEAL222AL2222016-08-31

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Primary DI, Brand, Company table
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04987671100627Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2025-08-22
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008408611023655008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
008408611024645008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023625008X HDF Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023795008X HDF Hemodialysis Blood Tubing Set with CLiC Blood ChamberFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611023865008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (TwFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
108408611024615008X Fluid Sampling AccessoryFresenius Medical Care Renal Therapies Group, LLCKOC2024-04-08
04987671400000Blood Tubing Lines for HemodialysisNIKKISO CO.,LTD.KOC2023-08-28
B144MPC825S0Molded Products, Inc.MOLDED PRODUCTS, INC.KOC2022-10-04
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04987671201102BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
24987671201106BLOOD TUBING LINES FOR HEMODIALYSISNIKKISO CO.,LTD.KOC2020-10-30
00842289102613Dialysis Priming SetNXSTAGE MEDICAL, INC.KOC2020-10-06
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