6000 NDGB - NDGB 20L DUAL BAG 2 ON/OFF VLV - HANS RUDOLPH, INC.

Duns Number:007131725

Device Description: NDGB 20L DUAL BAG 2 ON/OFF VLV

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More Product Details

Catalog Number

CR1999

Brand Name

6000 NDGB

Version/Model Number

6000

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

BTC

Product Code Name

Bag, Reservoir

Device Record Status

Public Device Record Key

2e3a659a-5fd0-439a-8296-9c945d6fff8e

Public Version Date

December 06, 2018

Public Version Number

1

DI Record Publish Date

November 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANS RUDOLPH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 922
2 A medical device with a moderate to high risk that requires special controls. 407