AirLife - Pad Covers for Biliblanket® Phototherapy - Carefusion Finland 320 Oy

Duns Number:367919120

Device Description: Pad Covers for Biliblanket® Phototherapy System, Disposable

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More Product Details

Catalog Number

6600-0270-200

Brand Name

AirLife

Version/Model Number

6600-0270-200

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"

-

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 Details

Product Code

FMZ

Product Code Name

INCUBATOR, NEONATAL

Device Record Status

Public Device Record Key

5fa3d481-4db2-4a88-81f3-e2fda20d420f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

50885403252912

Quantity per Package

5

Contains DI Package

70885403252916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CAREFUSION FINLAND 320 OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 363