BOX 2037A AUTO CONNECTION BOX MDR Medical Device Identification

GUDID 00763000306496

BOX 2037A AUTO CONNECTION BOX MDR

MEDTRONIC, INC.

Cardiac cryosurgical system

Primary Device ID	00763000306496
NIH Device Record Key	d86ce383-7f15-4b4e-bf37-faea2c916047
Commercial Distribution Status	In Commercial Distribution
Version Model Number	2037A
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

Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between -31 Degrees Fahrenheit and 136 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 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000306496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P020045

FDA Product Code

LPB	Cardiac ablation percutaneous catheter

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	2021-06-11
Device Publish Date	2021-06-03

Devices Manufactured by MEDTRONIC, INC.

00199150021055 - NA	2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
00199150021062 - NA	2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
00199150021079 - NA	2025-06-06 CUSTOM PACK BB7C59R10 E C L S
20199150021110 - NA	2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
20199150021134 - NA	2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA	2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA	2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA	2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE