AccessGUDID - DEVICE: PMI Probasics® (00841447104261)

GUDID

Device Identifier (DI) Information

Brand Name: PMI Probasics®
Version or Model: 7000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7000
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00841447104261
Issuing Agency: GS1
Commercial Distribution End Date: April 25, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: Suction Machine

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?
63643	Emergency airway clearance suction pump, electric	An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. It may include collection containers, microbial filter, valve, or tubing; it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a reusable 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 [?]
K042349	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 327a0600-5afa-4314-86c8-57a1f7a38e2b
Public Version Date: September 01, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016