Olympic Vac-Pac - Olympic Vac-Pac Size 30 - NATUS MEDICAL INCORPORATED

Duns Number:962519208

Device Description: Olympic Vac-Pac Size 30

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More Product Details

Catalog Number

51630

Brand Name

Olympic Vac-Pac

Version/Model Number

Size 30

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

de702feb-8528-41cc-b131-036f3f80037a

Public Version Date

January 10, 2020

Public Version Number

1

DI Record Publish Date

January 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NATUS MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 302
3 A medical device with high risk that requires premarket approval 5