AccessGUDID - DEVICE: LSU w/Reusable Canister, Canadian French (07045430042087)

GUDID

Device Identifier (DI) Information

Brand Name: LSU w/Reusable Canister, Canadian French
Version or Model: 78000016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 78000016
Company Name: Laerdal Medical AS

Primary DI Number: 07045430042087
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 730624095 *Terms of Use

Device Description: The LSU is a portable, electrically powered, medical suction equipment intended for field and transport use. It is intended for intermittent operation to remove secretions, blood or vomit from a patient's airway to allow ventilation. Hight vacuum levels are generally selected for oropharyngeal suctioning, and lower vacuum levels are usually selected for tracheal suctioning and the suctioning of children and infants.

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?
47366	Emergency airway clearance suction system, electric	A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart). It includes an electrically-powered suction pump, a collection container, and patient contact devices (e.g., handpiece/tip, mask), and typically also contains tubing and microbial/hydrophobic filters. The system is not intended for surgical use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993668	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
Storage Environment Temperature: between 0 and 40 Millimeter of Mercury
Storage Environment Humidity: between 0 and 95 Inches of Mercury

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 456a010f-7d08-4521-abdb-a7cbf00e6a02
Public Version Date: November 01, 2023
Public Version Number: 2
DI Record Publish Date: March 26, 2019