CABLE 5487L DISP STER ROHS 5PK Medical Device Identification

GUDID 20763000181165

CABLE 5487L DISP STER ROHS 5PK

MEDTRONIC, INC.

Electrical-only medical device connection cable, single-use

Primary Device ID	20763000181165
NIH Device Record Key	c471cf38-aee1-4e96-b202-126bac9f2761
Commercial Distribution Status	In Commercial Distribution
Version Model Number	5487L
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

Device Dimensions

Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter
Length	366 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000181161 [Primary]
GS1	20763000181165 [Package] Contains: 00763000181161 Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K960446

FDA Product Code

DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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	2024-09-09
Device Publish Date	2024-08-30

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