Duns Number:053146767
Device Description: SH 7-45 Bronchoscope Swivel - 15mm ID (patient port) x 15mm OD (equipment port). Reusable. SH 7-45 Bronchoscope Swivel - 15mm ID (patient port) x 15mm OD (equipment port). Reusable. 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.
Catalog Number
SH 7-45
Brand Name
SH 7-45 Bronchoscope Swivel
Version/Model Number
SH 7-45
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
3708664a-17eb-4003-9c25-7e96388483c9
Public Version Date
October 21, 2020
Public Version Number
4
DI Record Publish Date
September 17, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |