Glucertain 30180

GUDID 00856276008819

Glucertain Glucose Control Solution, Low, 50/box, 12 boxes/case

CELLERA LLC

Glucose IVD, control
Primary Device ID00856276008819
NIH Device Record Keydb80709f-a67f-40c8-883e-9cfdc4326a5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlucertain
Version Model Number30180
Catalog Number30180
Company DUNS960091929
Company NameCELLERA LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-892-2391
Emailsales@cellerallc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856276008819 [Primary]
GS120856276008813 [Package]
Package: box [50 Units]
In Commercial Distribution
GS130856276008810 [Package]
Contains: 20856276008813
Package: case [30 Units]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-07
Device Publish Date2018-11-06

On-Brand Devices [Glucertain]

30856276008827Glucertain Glucose Cntrol Solution, High, 50/box, 12 boxes/case
00856276008819Glucertain Glucose Control Solution, Low, 50/box, 12 boxes/case
B492301500Glucertain Blood Glucose Test Strips, 25/vial, 2 vials/box, 260 boxes/case
00850031608702Glucose Control Solution, Normal, 50/box, 12 boxes/case
00850031608122Safety Lancet, 28 ga., 100/box, 10 boxes/case
00850031608108Safety Lancet, 26 ga., 100/bx, 10 boxes/case
00850005565666Insulin Safety Syringes 0.5 ml 29 G x 1/2", 100/box, 5 boxes/case
00850005565642Insulin Safety Syringes 1 ml, 29 G x 1/2", 100/box, 5 boxes/case

Trademark Results [Glucertain]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLUCERTAIN
GLUCERTAIN
90232878 not registered Live/Pending
CellEra, LLC
2020-10-02
GLUCERTAIN
GLUCERTAIN
86830259 not registered Dead/Abandoned
CellEra, LLC
2015-11-24
GLUCERTAIN
GLUCERTAIN
85218105 4529872 Live/Registered
CellEra, LLC
2011-01-14

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