AccessGUDID - DEVICE: AincA® (B005LF1140)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: LF-114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LF-114
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005LF1140
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Test Lung, FLAT, 750cc, 22mmF Rubber Bushing, External Band, Green Neoprene/Foam

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
37709	Breathing circuit bag, reusable	A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTC	BAG, RESERVOIR

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
Total Volume: 0.75 Liter

Device Record Status

Public Device Record Key: f762502c-26b3-4d7b-b461-f072cf3549db
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021