GUDID 00643169889668

CABLE 5492AL LONG US MKT

MEDTRONIC, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00643169889668
NIH Device Record Key7109a123-bc3f-4533-9ae9-5c2212ba8a2a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5492AL
Company DUNS136201675
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169889668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[00643169889668]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-24

Devices Manufactured by MEDTRONIC, INC.

00763000763152 - NA2025-10-07 SW APP P7A2C11 ALTAVIVA CLINICIAN
00763000763817 - NA2025-10-07 SW APP P7A2P11 ALTAVIVA PATIENT
00763000929367 - Altaviva™2025-10-07 KIT P7K2C001 ALTAVIVA CLINICIAN
00763000935627 - Altaviva™2025-10-07 KIT P7K2P001 ALTAVIVA PATIENTA^
00763000936433 - Altaviva™2025-10-07 INS P7850N ALTAVIVA NEUROSTIMULATOR RC
00763000936440 - NA2025-10-07 ACCESSORY P71001 POCKET DISSECTOR
00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.