Micro G-Jet® - 14FR x 2.3 cm x 22 cm - AMT micro G-Jet® Low - APPLIED MEDICAL TECHNOLOGY, INC.

Duns Number:038101861

Device Description: 14FR x 2.3 cm x 22 cm - AMT micro G-Jet® Low Profile Transgastric-Jejunal Feeding Device 14FR x 2.3 cm x 22 cm - AMT micro G-Jet® Low Profile Transgastric-Jejunal Feeding Device (ENFit®)

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More Product Details

Catalog Number

MGJ-1423-22-I

Brand Name

Micro G-Jet®

Version/Model Number

MGJ-1423-22-I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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"

Yes

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

K183508

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

4450b22b-4a68-4014-ab73-290d13c26fb3

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

June 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"APPLIED MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 1325