MicroBlue®

GUDID 20763000040264

VENT TUBE 16191 5PK BLUE PEDIATRIC TITAN

MEDTRONIC XOMED, INC.

Tympanostomy tube Tympanostomy tube Tympanostomy tube
Primary Device ID20763000040264
NIH Device Record Key422661e3-1069-4200-a786-78567ad9e4d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroBlue®
Version Model Number16191
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

Device Dimensions

Lumen/Inner Diameter0.76 Millimeter
Lumen/Inner Diameter0.76 Millimeter
Lumen/Inner Diameter0.76 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000040260 [Primary]
GS100763000040260 [Primary]
GS100763000040260 [Primary]
GS120763000040264 [Package]
Contains: 00763000040260
Package: PK [5 Units]
In Commercial Distribution
GS120763000040264 [Package]
Contains: 00763000040260
Package: PK [5 Units]
In Commercial Distribution
GS120763000040264 [Package]
Contains: 00763000040260
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY
ETDTUBE, TYMPANOSTOMY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [MicroBlue®]

20763000040264VENT TUBE 16191 5PK BLUE PEDIATRIC TITAN
20763000040011VENT TUBE 14642 10PK MICROBLUE PAIR 1.27

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