CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, SINGLE - CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE - Intersurgical Incorporated

Duns Number:785952607

Device Description: CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, SINGLE PATIENT U CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, SINGLE PATIENT USE

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More Product Details

Catalog Number

-

Brand Name

CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M, SINGLE

Version/Model Number

1453013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K911422,K911422

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

0aab5b5d-1c11-4f22-ad66-f30c6fb067d9

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Additional Identifiers

Package DI Number

05030267144174

Quantity per Package

30

Contains DI Package

05030267144167

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"INTERSURGICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 101