AccessGUDID - DEVICE: Catheter Mount, Corrugated, Straight (06923310903608)

GUDID

Device Identifier (DI) Information

Brand Name: Catheter Mount, Corrugated, Straight
Version or Model: PA2941A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PA2941A
Company Name: Hangzhou Formed Medical Devices Co.Ltd.

Primary DI Number: 06923310903608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 560463769 *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:	Yes
Prescription Use (Rx):	No
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?
42476	Breathing circuit catheter mount, single-use	A device designed to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end; it may include an integrated suction port or be provided with a microbial medical gas filter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: Yes
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: b596d618-eaf3-4570-b777-df0ba4d24d4e
Public Version Date: December 21, 2022
Public Version Number: 1
DI Record Publish Date: December 13, 2022