RMS Precision Flow Rate TubingTM F3.8

GUDID 10659443000060

Flow Control Infusion Tubing

REPRO MED SYSTEMS, INC.

Mechanical infusion pump administration set
Primary Device ID10659443000060
NIH Device Record Key7d627be6-7dd9-4d4a-aa93-ea5af6265ab1
Commercial Distribution StatusIn Commercial Distribution
Brand NameRMS Precision Flow Rate TubingTM
Version Model NumberF3.8
Catalog NumberF3.8
Company DUNS048403299
Company NameREPRO MED SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com
Phone+1(845)610-5587
Emailfma@rmsmedpro.com

Device Dimensions

Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch
Lumen/Inner Diameter0.006 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Storage Environment TemperatureBetween 16 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100659443000063 [Primary]
GS110659443000060 [Package]
Contains: 00659443000063
Package: Carton [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, infusion

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

[10659443000060]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-19

On-Brand Devices [RMS Precision Flow Rate TubingTM]

00659443002722High Flow Rate Kit (2 x F275, 5 x F600, 5 x F900, 4 x F1200, 4 x F2400)
00659443002715Low Flow Rate Kit (3 x F30, 2 x F45, 8 x F60, 4 x F120, 3 x F180)
10659443000701Flow Control Infusion Tubing VHF
10659443000220Flow Control Infusion Tubing
10659443000213Flow Control Infusion Tubing
10659443000206Flow Control Infusion Tubing
10659443000190Flow Control Infusion Tubing
10659443000183Flow Control Infusion Tubing
10659443000176Flow Control Infusion Tubing
10659443000169Flow Control Infusion Tubing
10659443000152Flow Control Infusion Tubing
10659443000145Flow Control Infusion Tubing
10659443000138Flow Control Infusion Tubing
10659443000121Flow Control Infusion Tubing
10659443000114Flow Control Infusion Tubing
10659443000107Flow Control Infusion Tubing
10659443000091Flow Control Infusion Tubing
10659443000084Flow Control Infusion Tubing
10659443000077Flow Control Infusion Tubing
10659443000060Flow Control Infusion Tubing
10659443000053Flow Control Infusion Tubing
10659443000046Flow Control Infusion Tubing
10659443000039Flow Control Infusion Tubing
10659443000022Flow Control Infusion Tubing
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