AccessGUDID - DEVICE: VADI (04719894380384)

GUDID

Device Identifier (DI) Information

Brand Name: VADI
Version or Model: VH-210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 800-21101-CFS
Company Name: VADI MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 04719894380384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657254280 *Terms of Use

Device Description: Bacteria filter heater

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):	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?
36364	Bottle warmer	A mains electricity (AC-powered) heating device into which a bottle is intended to be placed for the preheating of its contents (e.g., milk for feeding infants, water, or other fluids). It typically consists of a tabletop device that has a well(s) for placement of the bottle(s), a heating element, a thermostat, and operating controls. It is designed to be portable for use in different locations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRQ	Unit, Heating, Powered

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
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: AC 100-120V

Device Record Status

Public Device Record Key: bf66e79e-73af-460d-9770-a4ab958c4a8e
Public Version Date: October 16, 2023
Public Version Number: 2
DI Record Publish Date: July 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
14719894380381	6	04719894380384		In Commercial Distribution	carton

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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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