SuperFlow Tubing Set

GUDID 10850082007049

Irrigation / Infiltration Tubing Set, Large

ARMM INC.

Surgical irrigation tubing set, single-use
Primary Device ID10850082007049
NIH Device Record Key5499331c-16c7-48a4-ad1b-03db106ca8ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuperFlow Tubing Set
Version Model Number21515
Company DUNS797391778
Company NameARMM INC.
Device Count10
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

Phone7148488190
Emailinfo@armminc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850082007042 [Unit of Use]
GS110850082007049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-08-29

On-Brand Devices [SuperFlow Tubing Set]

10850082007063Suction / Irrigation Wye Tubing Set
10850082007056Irrigation / Infiltration Tubing Set, 10 per Box
10850082007049Irrigation / Infiltration Tubing Set, Large
10850082007032Irrigation / Infiltration Tubing Set, Small
10850082007025Suction / Irrigation Wye Tubing Set with Valves
10850082007018Irrigation Tubing with Spike

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