KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ Medical Device Identification

GUDID 00763000228699

KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ

MEDTRONIC, INC.

Catheter/overtube balloon inflator, single-use

Primary Device ID	00763000228699
NIH Device Record Key	ea7d9c39-5a6d-4681-8b67-96b9edcaa8dd
Commercial Distribution Status	In Commercial Distribution
Version Model Number	20MRK
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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000228699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P100010

FDA Product Code

OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

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	2024-07-08
Device Publish Date	2024-06-28

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