AMT Mini ONE® Extension Set - 12" Mini ONE® BOLUS Non-PVC Feeding Set with - APPLIED MEDICAL TECHNOLOGY, INC.

Duns Number:038101861

Device Description: 12" Mini ONE® BOLUS Non-PVC Feeding Set with ENFit® and Cap (Pouched)

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More Product Details

Catalog Number

E8-1211-ISOSAF-NP; 8-1211-ISOSAF-NP

Brand Name

AMT Mini ONE® Extension Set

Version/Model Number

E8-1211-ISOSAF-NP

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"

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

K142989,K971757,K142989,K971757

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

8b06b7dc-ceac-4889-82f9-5068618302e8

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 19, 2021

Additional Identifiers

Package DI Number

00842071129217

Quantity per Package

10

Contains DI Package

00842071129057

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"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