AccessGUDID - DEVICE: DeVilbiss (00885304000532)

GUDID

Device Identifier (DI) Information

Brand Name: DeVilbiss
Version or Model: 7310PR-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7310PR-S
Company Name: DEVILBISS HEALTHCARE LLC

Primary DI Number: 00885304000532
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 962175894 *Terms of Use

Device Description: VACU-AIDE COMPACT, SPENCER, OPEN FRONT PORT, 12 V CORD NO PS

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:	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?
10749	Airway suction catheter	A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982304	000

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96ff62b5-d1ff-435d-b1f7-cd952f3b711a
Public Version Date: January 25, 2024
Public Version Number: 4
DI Record Publish Date: September 14, 2016