FISSO - FISSO Anaesthetic tube holder. This product is - Baitella AG

Duns Number:484942081

Device Description: FISSO Anaesthetic tube holder. This product is used to hold and position breathing tubes. FISSO Anaesthetic tube holder. This product is used to hold and position breathing tubes. Consisting of: Universal circuit holder plate for various Ø 14mm until Ø 30mm.

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More Product Details

Catalog Number

3628.13

Brand Name

FISSO

Version/Model Number

3628.13

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

-

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

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Device Record Status

Public Device Record Key

da4f382a-6292-44c1-80c3-573dd48ef52b

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BAITELLA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 1