N/A

GUDID 00643169571129

ACTV PA96000 PA US

MEDTRONIC, INC.

Cardiac pulse generator reader, home-use
Primary Device ID00643169571129
NIH Device Record Keyb807d61d-227d-48a3-b68f-1c9157d05e59
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberPA96000
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 Batchfalse
Serial Numbertrue
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

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169571129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

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 Date2015-10-28

On-Brand Devices [N/A]

00613994926005PRGM 97745 PAIN PTM INTELLIS PAPER LIT
00613994925985RECHRGR 97755 RTM PAIN INTELLIS PAPR LIT
00613994925961SCREENER 97725 PAIN WIRELESS DISP
00643169078574MONO SEALING HOOK 13-201-1 ENDO SH2.0
00643169078567MONO SEALER 13-121-1 DISSECTING DS3.5C
00643169078550MONO SEALER 13-101-1 DISSECTING DS3.0
00643169078543MONO SEALER 12-201-1 ENDO FL. BALL FB3.0
00643169986473ACCY KIT 355560 SCS EXTNSION PASSER 60CM
00643169986466ACCY KIT 355060 TUNNELING TOOL 1X8 60CM
00643169986435ACCY KIT 3550-68 TWST LOCK SCREEN CABLE
00643169986428ACCY KIT 3550-43 14GA NDL CURVD TIP 6IN
00643169986411ACCY KIT 355028 NEEDLE 14GA 6IN US
00643169986404ACCY KIT 3550-14 SCS 3.5 CURVED NEEDLE
00643169986398ACCY KIT 3550-P4 PASSING ELEVATOR KIT
00643169953710ACCY 3550-80 INTRSTIM 5 IN OZ WRNCH BOOT
00643169953703ACCY 3550-67 ALLIGATOR SCREEN CABLE US
00643169953697ACCY 3550-45 DBS 4 IN OZ TORQUE WRENCH
00643169953680ACCY 3550-29 PLUG CLOSED BOOT US
00643169953673ACCY 355025 BOOTS DBS US
00643169953666ACCY 355024 BOOTS ANCHORS US
00643169953642ACCY 3550-07 ALIGTR CLIP SCREEN CABLE US
00643169953635ACCY 3550-02 WRENCH AND SCREWS US
00643169953604ACCY 355538 SCS EXTENSION PASSER US
00643169953598ACCY 355038 1X8 38CM TUNNELING TOOL
00643169953581ACCY 3550-06 TUNNELING TOOL US
00643169953574ACCY 3550-05 PERC EXTNSN TUNNEL TOOL
00643169953567ACCY 3550-03 TWISTLOCK SCREENCABLE
00643169936614ADAPTOR 74002 2X4 SCS POCKET ADAPTOR
00643169936607ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR
00643169936591ADAPTOR 74001 1X4 SCS POCKET ADAPTOR
00643169936584ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR
00643169859661MONO SEALING HOOK 13-201-1 ENDO SH2.0
00643169859654MONO SEALER 13-121-1 DISSECTING DS3.5C
00643169859647MONO SEALER 13-101-1 DISSECTING DS3.0
00643169859630MONO SEALER 12-201-1 ENDO FL. BALL FB3.0
00643169855649SW APP A610 ACTIVA CLINICIAN DBS
00643169842212FOOTSWITCH 34-109-1 RF GENERATOR SYSTEM
00643169834330SW APP A521 GU PATIENT EVALUATION
00643169834323SW APP A511 GU CLINICIAN EVALUATION
00643169778061PROG 97745FA PAT THRPY MNGR FIXED ASSET
00643169778054PROG 8880T2 CLINICIAN TELEMMOD CTM2 US
00643169771048SW APP A820 TDD PATIENT PROG
00643169771031SW APP A810 TDD CLINICIAN PROG
00643169738065SW APP A902 PATIENT DATA SERVICES
00643169738058SW APP A901 COMM MANAGER
00643169738041SW APP A710 SCS CLINICIAN
00643169571129ACTV PA96000 PA US
00643169449107ACCESSORY 355025 BOOT MVD US
00763000187231COMM HANDSET KIT TH90GFA PH CLN FXD ASST
00763000058005COMM HANDSET KIT TH90G01 GU PROX US
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