V. Mueller - GENESIS CONTAINER BOTTOM SM NARROW, 5.5" (14CM) - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: GENESIS CONTAINER BOTTOM SM NARROW, 5.5" (14CM) DEEP LOW TEMPERATURE

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More Product Details

Catalog Number

R1843-ALT

Brand Name

V. Mueller

Version/Model Number

R1843-ALT

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRG

Product Code Name

Wrap, sterilization

Device Record Status

Public Device Record Key

2dbd6b67-df9e-40e7-8de0-956ba9970d3d

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAREFUSION 2200, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8016
2 A medical device with a moderate to high risk that requires special controls. 6223