NeoPAP Customer Trial Pack - Model # 1078535 – DI # B0361078535 – NeoPAP - CIRCADIANCE, LLC

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

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More Product Details

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

Product Characteristics

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 Details

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CIRCADIANCE, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 99