AccessGUDID - DEVICE: Cliq Aspirator (04712946602519)

GUDID

Device Identifier (DI) Information

Brand Name: Cliq Aspirator
Version or Model: DV-300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANEST IWATA SPARMAX Co., Ltd.

Primary DI Number: 04712946602519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658285132 *Terms of Use

Device Description: Aspirator, Powered Suction Pump.

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?
10219	Tracheal suction system	An assembly of devices designed to evacuate obstructive secretions, gas, liquids (e.g., blood, vomitus), and/or foreign bodies from the trachea. It generally consists of a mains electricity (AC-powered) suction pump, a pressure regulator and gauge, one or more collection canisters, plastic tubes connecting the components to each other, and an overflow protection and/or bacteria filter. The typical vacuum level is from 80 to 120 mm Hg to reduce the risk of trauma; free flow rates may be higher than 25 L/min. The system is used to remove secretions and to maintain the airway of an intubated patient; it is mainly used when suction from a central vacuum system is not available or appropriate.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 9d1723bb-37e7-4b8a-9e9c-12b8107f16a0
Public Version Date: February 13, 2019
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24712946602513	2	14712946602516		In Commercial Distribution
14712946602516	1	04712946602519		In Commercial Distribution

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

Customer Contact

[?]

Phone: +886223451868
Email: info@cliqmedical.com

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