Model: 1997000S
DI: 05030267089123
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
FIXED ELBOW, 15M - 22M/15F - STERILE
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
412dad2d-541d-45b6-83ce-40cb3507fec2
Distribution Status:
In Commercial Distribution
DUNS Number:
785952607
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
Yes
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
05030267089130
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
15
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05030267089123
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05030267089123
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
05030267089147
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
60
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
05030267089123
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 61346
Name: Straight/elbow breathing circuit connector, single-use
Definition:
A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.
FDA Product Codes
BZA
Connector, Airway (Extension)