AccessGUDID - DEVICE: ATTAIN CLARITY™ (00643169181717)

GUDID

Device Identifier (DI) Information

Brand Name: ATTAIN CLARITY™
Version or Model: 6225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169181717
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: Balloon Catheter 6225 Attain Clarity

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?
17613	Cardiac ventriculography catheter	A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQY	CATHETER, PERCUTANEOUS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121219	000

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
Storage Environment Temperature: less than 104 Degrees Fahrenheit
Storage Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Minimum guide catheter inner diameter 1.9 mm (5.7 Fr)
Device Size Text, specify: Nominal balloon diameter 13 mm
Device Size Text, specify: Catheter usable length 90 cm
Device Size Text, specify: Maximum guidewire diameter 0.018 in (0.46 mm)
Device Size Text, specify: Nominal inflation volume 2.5 ml
Device Size Text, specify: Maximum inflation volume 2.75 ml

Device Record Status

Public Device Record Key: 20c60478-ca94-4dae-bdee-e31104f50040
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: April 11, 2016

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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