AccessGUDID - DEVICE: AincA® (B005003320)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-332
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-332
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005003320
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Vaporizer, In Circuit, 22mmM x 22mmF x 30ga Injection Point (LuerF Lock w/ Cap), Chrome Brass

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":	Yes
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
CAD	VAPORIZER, ANESTHESIA, NON-HEATED

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: aee2c168-5c69-4a6e-970b-147c9074bee5
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021