NEOMED* - 0.5mL Oral Syringe Blue NonSterile - Avanos Medical, Inc.

Duns Number:079375431

Device Description: 0.5mL Oral Syringe Blue NonSterile

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More Product Details

Catalog Number

BB-S05EO

Brand Name

NEOMED*

Version/Model Number

BB-S05EO

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

-

Product Code Details

Product Code

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Device Record Status

Public Device Record Key

e3346528-5c01-4f9a-811f-45b1ff53c0f9

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

May 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVANOS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 269
2 A medical device with a moderate to high risk that requires special controls. 5221