PASSPORT PLUS MAIL-IN SYSTEM - Mail-in spore strips for use in monitoring the - SPS Medical Supply Corp.

Duns Number:194877072

Device Description: Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.

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More Product Details

Catalog Number

PP-052

Brand Name

PASSPORT PLUS MAIL-IN SYSTEM

Version/Model Number

PP-052

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

FRC

Product Code Name

Indicator, biological sterilization process

Device Record Status

Public Device Record Key

46f2ad5e-bba2-4aef-b2b8-234f521de392

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

50732224720802

Quantity per Package

4

Contains DI Package

10732224720804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"SPS MEDICAL SUPPLY CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26