AccessGUDID - DEVICE: HIgH-Flo™, RMS Precision Flow Rate TubingTM (00659443000698)

GUDID

Device Identifier (DI) Information

Brand Name: HIgH-Flo™, RMS Precision Flow Rate TubingTM
Version or Model: FEXT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FEXT
Company Name: REPRO MED SYSTEMS, INC.

Primary DI Number: 00659443000698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 048403299 *Terms of Use

Device Description: 24" Tubing Extender

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:	Yes
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?
46846	Mechanical infusion pump administration set	A collection of devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication (not included), typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 16 and 30 Degrees Celsius
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Inch

Device Record Status

Public Device Record Key: 5fe31f3f-3f14-45be-aa0c-f6d34df62054
Public Version Date: April 03, 2024
Public Version Number: 3
DI Record Publish Date: August 19, 2016