Ave 2 - Electrical birthing bed - L I N E T spol. s r.o.

Duns Number:644544504

Device Description: Electrical birthing bed

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More Product Details

Catalog Number

-

Brand Name

Ave 2

Version/Model Number

4BCPPB3-4GC03C1

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)

-

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

HDD

Product Code Name

Table, Obstetrical, Ac-Powered (And Accessories)

Device Record Status

Public Device Record Key

81e50e82-3738-495b-b704-565fd3188c2d

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"L I N E T SPOL. S R.O." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 196