AccessGUDID - DEVICE: AincA® (B00500200SMRI0)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: 00-200-S-MRI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-200-S-MRI
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B00500200SMRI0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Manometer, Pole Mount Clamp, MRI Cond 3T, for 3/8" to 1.5" dia Pole, w/Hardware, fits 00-199-MRI Gauges

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
46634	Airway pressure monitor, non-powered	A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)

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: e49074ae-7baf-49b9-b445-25094932786d
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021