Model: 23001
DI: B245230010
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2017-02-13
Current Version: 2026-05-13
Description
Onboard Suction Device
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
4
Record Key:
a676298e-19a4-466f-8c08-a431448dc0db
Distribution Status:
In Commercial Distribution
DUNS Number:
131254971
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
B245230010
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
HIBCC
Item #2 - Pkg Type:
Carton
Item #2 - Device ID:
B245230011
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
B245230010
Item #2 - Device ID Issuing Agency:
HIBCC
GMDN
Code: 47366
Name: Emergency airway clearance suction system, electric
Definition:
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.
FDA Product Codes
GCX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered