AccessGUDID - DEVICE: SIUI (06938396497002)

GUDID

Device Identifier (DI) Information

Brand Name: SIUI
Version or Model: CR-30A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shantou Institute of Ultrasonic Instruments Co., Ltd.

Primary DI Number: 06938396497002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654090299 *Terms of Use

Device Description: CR Series Trolley, CR Series Cart, used to transport medical ultrasound machines.

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:	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?
34909	Instrument trolley	A cart used to transport medical and surgical instruments, and sometimes sterile supplies, from a central supply station or sterilization department to appropriate areas of the hospital [e.g., the operating room (OR)]. In sterilizing departments the trolley may be used in the sterilizing process, and for sterilized instruments the cart may be designed to accommodate sterile wraps/packaging and/or cases. This trolley (cart) can be closed or open (open trolleys are usually covered with fabric during transport).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)

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: b59476d6-292e-4df6-9a37-8d69b84e4213
Public Version Date: September 20, 2019
Public Version Number: 1
DI Record Publish Date: September 12, 2019