AccessGUDID - DEVICE: Nebulizer Kit (06973401840022)

GUDID

Device Identifier (DI) Information

Brand Name: Nebulizer Kit
Version or Model: OWWHQ-1901PT(408D)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.

Primary DI Number: 06973401840022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 550888712 *Terms of Use

Device Description: Nebulizer Machine Mask parts, cool mist inhaler accessories tubing, mask kit, including tunbing (74 inch), mask for kids, mask for adult, mouthpiece by only warm.

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):	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?
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	Mask, Oxygen

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: Yes
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: 9f9be176-c557-41f6-b8d9-5d9f65462ac6
Public Version Date: July 24, 2020
Public Version Number: 1
DI Record Publish Date: July 16, 2020