Aligned Medical Solutions - PICC Insertion Tray-RX - Aligned Medical Solutions

Duns Number:106580145

Device Description: PICC Insertion Tray-RX

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More Product Details

Catalog Number

VYMAXBASIC

Brand Name

Aligned Medical Solutions

Version/Model Number

VYMAXBASIC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRO

Product Code Name

General surgery tray

Device Record Status

Public Device Record Key

92d196fa-3c05-4ba6-9b3e-688bc7853a18

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 18, 2019

Additional Identifiers

Package DI Number

B098VYMAXBASIC1

Quantity per Package

10

Contains DI Package

B098VYMAXBASIC0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ALIGNED MEDICAL SOLUTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 578
2 A medical device with a moderate to high risk that requires special controls. 1711