Nonin Adapter Box Assy for Watch-PAT 200i - Nonin Adapter Box Assy WP200 Bracelet Comp. - ITAMAR MEDICAL LTD

Duns Number:531857076

Device Description: Nonin Adapter Box Assy WP200 Bracelet Comp. (Recertified)

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More Product Details

Catalog Number

US2250305

Brand Name

Nonin Adapter Box Assy for Watch-PAT 200i

Version/Model Number

Nonin Adapter Box Assy for Watch-PAT 200i

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

K081037

Product Code Details

Product Code

MNR

Product Code Name

Ventilatory Effort Recorder

Device Record Status

Public Device Record Key

23c58ce0-ee3b-41ce-8f4e-7d2075c68e26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ITAMAR MEDICAL LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 24