DEVICE: Arctic Front Advance Pro™ (00763000088637)

Device Identifier (DI) Information

Arctic Front Advance Pro™
AFAPRO28
Not in Commercial Distribution

MEDTRONIC, INC.
00763000088637
GS1
June 24, 2022
1
006261481 *Terms of Use
CATH AFAPRO28 AFA PRO 28MM US PB
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60720 Cardiac cryosurgical system catheter
A sterile, flexible device intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and deliver pressurized liquid refrigerant (e.g., nitrous oxide) to its distal cooling segment to achieve extremely low temperatures through gas expansion; it typically includes sensors (e.g., temperature monitoring). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OAE Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P100010 084
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
Handling Environment Temperature: between -31 and 113 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter shaft size 10.5 Fr
Device Size Text, specify: Catheter tip width 28 mm
Length: 95.0 Centimeter
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Device Record Status

719b5cc0-b4b5-4986-9942-34dd67e8cbed
July 06, 2023
2
March 23, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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