AccessGUDID - DEVICE: FRU T-Handle (00813830020304)

GUDID

Device Identifier (DI) Information

Brand Name: FRU T-Handle
Version or Model: 24549
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 24549
Company Name: ACCUTRON, INC.

Primary DI Number: 00813830020304
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 088302096 *Terms of Use

Device Description: No description.

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):	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?
16953	Inhalational analgesia unit	A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. The unit will typically include a demand valve; some may be connected to a vaporizer calibrated for the administration of analgesic concentrations of inhalational anaesthetic agents. Typically used: 1) during labour to help the patient retain her consciousness while pain sensations are subdued; or 2) in dentistry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSZ	Gas-Machine, Anesthesia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970163	000

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: a4d10d46-04d0-468c-b870-82531f793d40
Public Version Date: November 01, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016