Rosie SmartMeter Professional Strip 3L-10-16003E

GUDID 03894540005253

Rosie SmartMeter Professional Strip-Foil

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, point-of-care
Primary Device ID03894540005253
NIH Device Record Key5c0df941-c310-44ec-a2fa-89921d9fe9a7
Commercial Distribution Discontinuation2016-12-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRosie SmartMeter Professional Strip
Version Model NumberAC-11 Pro-Strip
Catalog Number3L-10-16003E
Company DUNS658644174
Company NameHMD BIOMEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100868665000052 [Primary]
GS103894540005253 [Package]
Contains: 00868665000052
Package: [240 Units]
Discontinued: 2016-12-07
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-27
Device Publish Date2016-12-07

On-Brand Devices [Rosie SmartMeter Professional Strip]

00389454000525Rosie SmartMeter Professional Strip-Foil
03894540005253Rosie SmartMeter Professional Strip-Foil

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