AccessGUDID - DEVICE: ACHIEVE™ (00643169489080)

GUDID

Device Identifier (DI) Information

Brand Name: ACHIEVE™
Version or Model: 990063-015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169489080
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 990063-015 ACHIEVE 15MM US

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?
46355	Cardiac mapping catheter, percutaneous, single-use	A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRF	CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102588	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: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between -35 and 58 Degrees Celsius
Special Storage Condition, Specify: Keep Dry
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep away from heat and sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Effective Length 146 cm
Device Size Text, specify: Catheter Size 3.3 Fr
Device Size Text, specify: Electrode Spacing 4 mm
Device Size Text, specify: Overall Length 165 cm
Device Size Text, specify: Tip Diameter 15 mm

Device Record Status

Public Device Record Key: ac5df4f3-1ccd-4bf7-adef-70a234041802
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: April 08, 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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