Duns Number:830432451
Device Description: Limb-O™ Single Limb Anesthesia Breathing Circuit
Catalog Number
5510
Brand Name
Limb-O
Version/Model Number
5510
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
Public Device Record Key
bfc2b583-b8f5-4e70-b533-c576c35b438c
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
50885403289857
Quantity per Package
20
Contains DI Package
10885403289859
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |