AccessGUDID - DEVICE: LSU w/Serres Suction Bag Canister, Canadian French (07045432030822)

GUDID

Device Identifier (DI) Information

Brand Name: LSU w/Serres Suction Bag Canister, Canadian French
Version or Model: 78003016
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 78003016
Company Name: Laerdal Medical AS

Primary DI Number: 07045432030822
Issuing Agency: GS1
Commercial Distribution End Date: March 12, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 730624095 *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:	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 Humidity: between 0 and 95 Inches of Mercury
Storage Environment Temperature: between 0 and 40 Millimeter of Mercury

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6b4e252-55a8-4a0d-a28b-9a77cf9f5f43
Public Version Date: March 13, 2020
Public Version Number: 2
DI Record Publish Date: March 26, 2019