GUDID 00763000632793

SW APP A820 TDD PATIENT PROG V2.X

MEDTRONIC, INC.

Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer Infusion pump programmer
Primary Device ID00763000632793
NIH Device Record Keyafd6a5c3-0183-4973-9ce6-3ac574ceb548
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberA820
Company DUNS796986144
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
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 Identifiers

Device Issuing AgencyDevice ID
GS100763000632793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLKLegging, compression, non-inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-05

Devices Manufactured by MEDTRONIC, INC.

00763000944322 - NA2024-04-23 CUSTOM PACK HY4953R31 MEMB PK
00763000944339 - NA2024-04-23 CUSTOM PACK BB12F73R1 AHO PACK
00763000944346 - NA2024-04-23 CUSTOM PACK BB12F35R5 A PACK
00763000945558 - NA2024-04-23 CUSTOM PACK CB11X44R5 3/16X1/4 NEO
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

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