Catalog Number

-

Brand Name

Hometa

Version/Model Number

G-G10-1A03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150687,K150687

Product Code

FLN

Product Code Name

Monitor, Electric For Gravity Flow Infusion Systems

Public Device Record Key

42912ade-85ba-4c27-9a2a-ea9ee32cd26e

Public Version Date

November 13, 2020

Public Version Number

1

DI Record Publish Date

November 05, 2020

Package DI Number

10850024592077

Quantity per Package

40

Contains DI Package

00850024592070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case