DEVICE: DS 7-45 Bronchoscope Swivel (M996DS7450)

Device Identifier (DI) Information

DS 7-45 Bronchoscope Swivel
DS 7-45
In Commercial Distribution
DS 7-45
INSTRUMENTATION INDUSTRIES, INCORPORATED
M996DS7450
HIBCC

1
053146767 *Terms of Use
DS 7-45 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x 15mm OD (equipment port). Fits components of adult ventilator circuits. Includes one thermoplastic rubber cap; cap allows for the use of a suctioning catheter or fiber-optic bronchoscope without significant loss of PEEP. Single-Patient Use.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
61346 Straight/elbow breathing circuit connector, single-use
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
BZA Connector, Airway (Extension)
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

67f90b97-b4c9-4745-80f7-8617bd111401
November 28, 2022
3
May 26, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
M996DS7454 25 M996DS7450 In Commercial Distribution Ziplock bag
M996DS7455 50 M996DS7450 In Commercial Distribution Ziplock bag
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
412-854-1133
raqa@iiimedical.com
CLOSE