N/A

GUDID 00763000118280

MAPPING SYSTEM CIT200 US

MEDTRONIC, INC.

Cardiac mapping system

• Primary Device ID: 00763000118280
• NIH Device Record Key: f4d2c5a4-9871-4127-bea2-58bd73f3e411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: CIT200
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not stack
• Handling Environment Temperature: Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000118280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181918

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-31

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• 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