Armstrong V Activent®

GUDID 20681490030841

VENT TUBE 1036121 5PK ARMSTRONG V 4.5

MEDTRONIC XOMED, INC.

Tympanostomy tube
Primary Device ID20681490030841
NIH Device Record Key136b9217-6ab5-482c-984c-a04f3868b4e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameArmstrong V Activent®
Version Model Number1036121
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0
Length4.5 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490030847 [Primary]
GS120681490030841 [Package]
Contains: 00681490030847
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-17

Devices Manufactured by MEDTRONIC XOMED, INC.

00763000003036 - NIM Vital™2024-11-15 CONN CABLE NIM4CPB2 PAT INTFC NIM 4.0
00763000842543 - Bipolar Stimulating Probe2024-11-04 PROBE 8225351 5PK CONCEN BIPO STIM ROHS
00763000842550 - Bipolar Stimulating Probe2024-11-04 PROBE 8225401 5PK SD-SD BIPOL STIM ROHS
00763000842567 - Bipolar Stimulating Probe2024-11-04 PROBE 8225451 5PK PRASS BIPO STIMUL ROHS
00763000891862 - ENT NIM Electrode2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS
00763000891879 - ENT NIM Electrode2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS
00763000580483 - ENT NIM Vital2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS
00763000578022 - N/A2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.