N/A - EDMS 46126 PATIENT CONN LINE ASSY - MEDTRONIC PS MEDICAL, INC.

Duns Number:089055867

Device Description: EDMS 46126 PATIENT CONN LINE ASSY

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

46126

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

Yes

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

K984053

Product Code Details

Product Code

GWM

Product Code Name

Device, monitoring, intracranial pressure

Device Record Status

Public Device Record Key

f3673442-1a9e-4f00-898a-6b92e7ddb835

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC PS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 1465