Device
Sunset Pediatric Active Circuit, Non-Heated, ResMed - Similar to 21312 and 21322
Manufacturer
SUNSET HEALTHCARE SOLUTIONS, INC.
SUNSET HEALTHCARE SOLUTIONS, INC.
Model: VC1001P-R
DI: 00848530108861
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Sunset Pediatric Active Circuit, Non-Heated, ResMed - Similar to 21312 and 21322
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fafa3692-4dad-4804-a3af-3cd816222009
Distribution Status:
In Commercial Distribution
DUNS Number:
141668116
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10848530108868
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
60
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00848530108861
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00848530108861
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 37704
Name: Anaesthesia breathing circuit, single-use
Definition:
An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.
FDA Product Codes
BZO
Set, Tubing And Support, Ventilator (W Harness)