AccessGUDID - DEVICE: Reveal LINQ™ (00643169845749)

GUDID

Device Identifier (DI) Information

Brand Name: Reveal LINQ™
Version or Model: LNQ11
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169845749
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: MON LNQ11 REVEAL LINQ USA FW2.0

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
47804	Implantable cardiac monitor	A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSI	DETECTOR AND ALARM, ARRHYTHMIA
MXD	Recorder, event, implantable cardiac, (with arrhythmia detection)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162855	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
Handling Environment Temperature: between -18 and 55 Degrees Celsius
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a567b7de-11c6-48e4-b826-5e43c9d1e435
Public Version Date: August 14, 2023
Public Version Number: 6
DI Record Publish Date: March 10, 2017

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: No
Serial Number: Yes
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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