GUDID 00643169023581

ADAPTER 1036BY OHMEDA Y-BLOCK HOSE

MEDTRONIC, INC.

Vacuum quick-connect coupling, male
Primary Device ID00643169023581
NIH Device Record Keyc0258e1c-603d-4653-8b49-3e3faa196123
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1036BY
Company DUNS006261481
Company NameMEDTRONIC, 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 Usefalse
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169023581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

20199150041118 - NA2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE
20199150041132 - NA2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT
00763000876982 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12506X SPR LEG RX US M
00763000876999 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12510X SPR LEG RX US M
00763000877002 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12512X SPR LEG RX US M
00763000877019 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12515X SPR LEG RX US M
00763000877026 - SPRINTER® LEGEND2025-08-18 BALLOON SPL12520X SPR LEG RX US M
00763000925079 - FlexCath Cross™ Transseptal Solution2025-08-18 NDL 900300 FLEXCATH CROSS AG 61CM EIFU

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.