CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR Medical Device Identification

GUDID 00763000443214

CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR

MEDTRONIC, INC.

Electrical-only medical device connection cable, single-use

Primary Device ID	00763000443214
NIH Device Record Key	8d322dff-bc88-4bec-a038-2707bc6865c7
Commercial Distribution Status	In Commercial Distribution
Version Model Number	2ACHC
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
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter
Length	1.96 Meter

Operating and Storage Conditions

Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000443214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153139

FDA Product Code

DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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	2024-05-27
Device Publish Date	2024-05-18

Devices Manufactured by MEDTRONIC, INC.

20763000825380 - NA	2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG
20763000984193 - NA	2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG
20763000982946 - NA	2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD
00763000984007 - NA	2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG
00763000984021 - NA	2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE
00763000984151 - NA	2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT
00763000984168 - NA	2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS
00763000984175 - NA	2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK