AccessGUDID - DEVICE: Freezor® MAX (00643169450387)

GUDID

Device Identifier (DI) Information

Brand Name: Freezor® MAX
Version or Model: 239F5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169450387
Issuing Agency: GS1
Commercial Distribution End Date: June 21, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CATHETER 239F5 FREEZOR MAX5 LG ORANGE9F

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
LPB	Cardiac ablation percutaneous catheter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100010	037

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -31 and 136 Degrees Fahrenheit
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Shaft size 9 Fr
Device Size Text, specify: Curve length 66 mm
Length: 90.0 Centimeter
Device Size Text, specify: Tip length 8 mm

Device Record Status

Public Device Record Key: ff9919b4-c70b-4539-b5e4-3853631051ed
Public Version Date: July 10, 2018
Public Version Number: 4
DI Record Publish Date: December 01, 2014

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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