GUDID 00643169023833

ADAPTER 1036K PURITAN WAGD MALE

MEDTRONIC, INC.

Vacuum quick-connect coupling, male Vacuum quick-connect coupling, male
Primary Device ID00643169023833
NIH Device Record Keye4d6414a-9574-4af6-8650-8309c45fec09
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1036K
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

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169023833 [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.

00763000943844 - NA2024-04-12 CUSTOM PACK BB11J59R5 PEDS
00763000943851 - NA2024-04-12 CUSTOM PACK BB12F35R3 A PACK
00763000943868 - NA2024-04-12 CUSTOM PACK CB9J12R4 PED SPRT
00763000943899 - NA2024-04-12 CUSTOM PACK BB12E09R3 INVO DCD
00763000943882 - NA2024-04-12 CUSTOM PACK BB12C41R4 10PK LUNG PACK
00763000825539 - NA2024-04-08 REV KIT 8598A SPNL SGMNT CATH EMAN
00763000893491 - SHERPA NX BALANCED™2024-04-08 CATHETER SB6CHAMP05SH SB 6F 100CM CH05
20763000933412 - NA2024-04-08 CUSTOM PACK 12F60R 10PK VENTED SPIKE

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