AccessGUDID - DEVICE: GloTran VHP Plasma Disinfector (00868536000433)

GUDID

Device Identifier (DI) Information

Brand Name: GloTran VHP Plasma Disinfector
Version or Model: GT35H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: You First Services, Inc.

Primary DI Number: 00868536000433
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061191200 *Terms of Use

Device Description: No description.

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):	No
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?
63203	Plasma device disinfector	A mains electricity (AC-powered) device designed to destroy microorganisms (disinfect) from medical devices and related products using hydrogen peroxide (H2O2) gas in plasma state; it is typically used for products sensitive to high temperature and humidity. It typically includes a treatment chamber with a H2O2 gas inlet, a vacuum pump, a radio-frequency generator with electrodes intended to convert the vapour into plasma, and the appropriate controls. It is typically intended to disinfect devices after cleaning of gross debris; it is not intended to wash devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEC	Disinfector, Medical Devices

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: 65537f18-240f-43a9-ac67-e9324774797a
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: July 08, 2022

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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