AccessGUDID - DEVICE: FREEDOM60® (00659443000001)

GUDID

Device Identifier (DI) Information

Brand Name: FREEDOM60®
Version or Model: F10050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F10050
Company Name: REPRO MED SYSTEMS, INC.

Primary DI Number: 00659443000001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048403299 *Terms of Use

Device Description: Mechanical Syringe Infusion Pump

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46541	Elastomeric infusion pump system filling device	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKP	Immunoglobulin G (IgG) Infusion System
FPA	Set, administration, intravascular
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162613	000
K933652	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f3b809fa-d1bc-48f2-ba65-2eeb27710c60
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 19, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(845)610-5587
Email: fma@rmsmedpro.com

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