KBMED - Enteral Feeding Syringe 60ml blister packing - KB Medical (group), Inc.

Duns Number:105002071

Device Description: Enteral Feeding Syringe 60ml blister packing

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More Product Details

Catalog Number

-

Brand Name

KBMED

Version/Model Number

ES60

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182649,K182649

Product Code Details

Product Code

PNR

Product Code Name

Enteral Syringes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

45b28066-4374-456f-820c-55fc9176b40c

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

January 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KB MEDICAL (GROUP), 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. 10