i.Series® - Pharmacy Refrigerator - Pass-Thru, 26.5 cu ft - HELMER, INC.

Duns Number:086685682

Device Description: Pharmacy Refrigerator - Pass-Thru, 26.5 cu ft

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More Product Details

Catalog Number

-

Brand Name

i.Series®

Version/Model Number

iPR226-GX

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Device Record Status

Public Device Record Key

05a1d08a-6dbe-48f5-9394-292fbe5ac1da

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 31, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HELMER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 151