Duns Number:012721295
Device Description: Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3;Model # 1078536 – DI # B0361 Model # 1078535 – DI # B0361078535 – NeoPAP Bonnet XS – Qty 3;Model # 1078536 – DI # B0361078536 – NeoPAP Bonnet S – Qty 3;Model # 1078537 – DI # B0361078537 – NeoPAP Bonnet M – Qty 3;Model # 1078538 – DI # B0361078538 – NeoPAP Bonnet L – Qty 2;Model # 1078539 – DI # B0361078539 – NeoPAP Bonnet XL – Qty 2;Model # 1110290 – DI # B0361110290 – NeoPAP Cannula XXS – Qty 2;Model # 1078611 – DI # B0361078611 – NeoPAP Cannula XS – Qty 2;Model # 1078612 – DI # B0361078612 – NeoPAP Cannula S – Qty 2;Model # 1078613 – DI # B0361078613 – NeoPAP Cannula M – Qty 2;Model # 1078614 – DI # B0361078614 – NeoPAP Cannula L – Qty 2;Model # 1078616 – DI # B0361078616 – NeoPAP Cannula XL – Qty 2;Model # 1078667 – DI # B0361078667 – NeoPAP Nasal Mask S – Qty 5;Model # 1078668 – DI # B0361078668 – NeoPAP Nasal Mask L – Qty 5;Model # 1078582 – DI # B0361078582 – NeoPAP Pressure Line & Sizing Kit – Qty 10
Catalog Number
1078602
Brand Name
NeoPAP Customer Trial Pack
Version/Model Number
1078602
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"
-
For Single-Use
-
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
K103410,K103410
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
abf3d8ec-f7d6-40ec-96b6-cdfb8122e49c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 99 |