N/A

GUDID 00763000280024

CABLE 2ACHC ACHIEVE ADVANCE 10-PIN

MEDTRONIC, INC.

Cardiac mapping catheter, percutaneous, single-use

Primary Device ID	00763000280024
NIH Device Record Key	4e4c09dd-926e-443f-9567-012a66f609d8
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	2ACHC
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter

Operating and Storage Conditions

Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep Dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000280024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153139

FDA Product Code

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-11-04
Device Publish Date	2019-10-25

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