AccessGUDID - DEVICE: RIKEN KEIKI Co.,Ltd. (04571501890019)

GUDID

Device Identifier (DI) Information

Brand Name: RIKEN KEIKI Co.,Ltd.
Version or Model: FI-8000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PC3E-0421
Company Name: RIKEN KEIKI CO.,LTD.

Primary DI Number: 04571501890019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690573670 *Terms of Use

Device Description: ANALYZER,GAS,HALOTANE,GASEOUS-PHASE(ANESTHETICCONC.)

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?
36792	Anaesthesia vaporizer tester	A device designed to evaluate and display the performance of an anaesthetic vaporizer; it may also be used to assist in the calibration of the vaporizer. Currently, most types are electronic but some may be mechanical. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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: 710ede80-bd74-49a8-82cf-569942689d3b
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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

Customer Contact

[?]

No Customer Contact currently defined

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