AccessGUDID - DEVICE: Vermed Holter Kit (10813150021545)

GUDID

Device Identifier (DI) Information

Brand Name: Vermed Holter Kit
Version or Model: KIT-HAN8
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KIT-HAN8
Company Name: GRAPHIC CONTROLS ACQUISITION CORP

Primary DI Number: 10813150021545
Issuing Agency: GS1
Commercial Distribution End Date: August 21, 2018
Device Count: 50
Labeler D-U-N-S® Number*: 002111896 *Terms of Use

Device Description: Packed for Hankins Surgical Supply 50 KITS PER CASE

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62149	Electrocardiographic long-term ambulatory recording support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7bc91cc8-fcbb-430a-a0ef-315c24479d17
Public Version Date: August 22, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2017