Catalog Number

FPRCH6107

Brand Name

Helium Supply Line (8 m), psi

Version/Model Number

FPRCH6107

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 15, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Public Device Record Key

db1d965f-71b3-4db2-8074-fb51f9590b15

Public Version Date

April 08, 2022

Public Version Number

7

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-