AccessGUDID - DEVICE: AincA® (B005LF124200)

GUDID

Device Identifier (DI) Information

Brand Name: AincA®
Version or Model: LF-124-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LF-124-20
Company Name: ANESTHESIA ASSOCIATES, INC.

Primary DI Number: B005LF124200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002065670 *Terms of Use

Device Description: Bag, Breathing, FLUTED, 22mmF Rubber Bushing, 2 Liter, Black Conductive Neoprene

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: 2 Liter

Device Record Status

Public Device Record Key: 4b67d2f4-156a-4b04-afa8-578ec89c2677
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021