AccessGUDID - DEVICE: Gongdong (06947462400228)

GUDID

Device Identifier (DI) Information

Brand Name: Gongdong
Version or Model: G1047W
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06947462400228
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10000
Labeler D-U-N-S® Number*: 529309049 *Terms of Use

Device Description: Tube cover, 13x75, PE

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?
62229	Test tube/reservoir cap	A covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: a09863fd-4206-41f8-b82f-a04a22d8dd06
Public Version Date: August 12, 2022
Public Version Number: 1
DI Record Publish Date: August 04, 2022