Device
Sampling line, dimension: 3mm*ø4.7mm*200cm
Manufacturer
SUNSET HEALTHCARE SOLUTIONS, INC.
SUNSET HEALTHCARE SOLUTIONS, INC.
Model: VEN007
DI: 00848530108809
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Sampling line, dimension: 3mm*ø4.7mm*200cm
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
216bf899-1dfe-44e0-ba17-097ef08867f6
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10848530108806
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
100
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00848530108809
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00848530108809
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 45566
Name: Gas-sampling/monitoring respiratory tubing, single-use
Definition:
A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.
FDA Product Codes
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)