Duns Number:141668116
Device Description: Sunset Healthcare Durable CPAP Tubing 4 Foot 19mm I.D. with 22mm Cuffs Gray
Catalog Number
TUB004
Brand Name
Sunset Healthcare Durable CPAP Tubing 4 Foot 19mm I.D. with 22mm Cuffs Gray
Version/Model Number
TUB004
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"
-
For Single-Use
-
Prescription Use (Rx)
-
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
b0b6de9d-635c-458a-8003-206adc60a6f9
Public Version Date
October 22, 2018
Public Version Number
1
DI Record Publish Date
September 19, 2018
Package DI Number
10848530070059
Quantity per Package
25
Contains DI Package
00848530070052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 160 |
2 | A medical device with a moderate to high risk that requires special controls. | 68 |