AccessGUDID - DEVICE: HScribe (00817655022635)

GUDID

Device Identifier (DI) Information

Brand Name: HScribe
Version or Model: 11110-005-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MORTARA INSTRUMENT, INC.

Primary DI Number: 00817655022635
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062046149 *Terms of Use

Device Description: Holter Analysis System Software

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:	No
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?
41651	Electrocardiographic long-term ambulatory recording analyser application software	A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K004017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: less than 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2ecc1ae-2f78-44c0-8883-0f485dcff48a
Public Version Date: June 29, 2020
Public Version Number: 4
DI Record Publish Date: November 02, 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: 888-667-8272
Email: techsupport@mortara.com

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