FDA.reportPublic FDA data

FREEDOM60®

Primary DI
00659443000001
Brand
FREEDOM60®
Company
REPRO MED SYSTEMS, INC.
Model
F10050
Catalog number
F10050
Device description
Mechanical Syringe Infusion Pump
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular
FRNPump, infusion
PKPImmunoglobulin G (IgG) Infusion System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
FRNPump, InfusionGeneral Hospital2
PKPImmunoglobulin G (Igg) Infusion SystemGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162613000
K933652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162613000Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products2017-08-31FRN
K933652000FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGRepro-Med Systems, Inc.1994-05-18FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00659443000001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00659443000001006594430000016594430000010659443000001

GMDN Terms#

Term, Definition table
TermDefinition
Elastomeric infusion pump system filling deviceA device that is used to fill an elastomeric infusion pump system chamber with a prescribed medicated solution, to create the pressure required to expand the elastic chamber and the subsequent force that infuses the solution into the patient/user when connected. The device typically holds a syringe prefilled with the solution, and has a handle or lever that is used to push the syringe plunger inward to force the solution into the elastomeric chamber. This device is typically designed for use by a layperson. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(845)610-5587fma@rmsmedpro.com

Regulatory Flags#

DUNS number
048403299
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00659443000230HIgH-Flo™ Needle SetRMS12604RMS126042016-08-19
00659443000247HIgH-Flo™ Needle SetRMS12609RMS126092016-08-19
00659443000254HIgH-Flo™ Needle SetRMS12606RMS126062016-08-19
00659443000261HIgH-Flo™ Needle SetRMS12612RMS126122016-08-19
00659443000278HIgH-Flo™ Needle SetRMS12614RMS126142016-08-19
00659443000285HIgH-Flo™ Needle SetRMS22604RMS226042016-08-19
00659443000292HIgH-Flo™ Needle SetRMS22606RMS226062016-08-19
00659443000308HIgH-Flo™ Needle SetRMS22609RMS226092016-08-19
00659443000315HIgH-Flo™ Needle SetRMS22612RMS226122016-08-19
00659443000322HIgH-Flo™ Needle SetRMS22614RMS226142016-08-19
00659443000339HIgH-Flo™ Needle SetRMS32604RMS326042016-08-19
00659443000346HIgH-Flo™ Needle SetRMS32606RMS326062016-08-19
00659443000353HIgH-Flo™ Needle SetRMS32609RMS326092016-08-19
00659443000360HIgH-Flo™ Needle SetRMS32612RMS326122016-08-19
00659443000377HIgH-Flo™ Needle SetRMS32614RMS326142016-08-19
00659443000384HIgH-Flo™ Needle SetRMS42604RMS426042016-08-19
00659443000391HIgH-Flo™ Needle SetRMS42606RMS426062016-08-19
00659443000407HIgH-Flo™ Needle SetRMS42609RMS426092016-08-19
00659443000414HIgH-Flo™ Needle SetRMS42612RMS426122016-08-19
00659443000421HIgH-Flo™ Needle SetRMS42614RMS426142016-08-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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