Baebies 0975

GUDID 00819704020043

Quality Control Dried Blood Spot - Low

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, control
Primary Device ID00819704020043
NIH Device Record Key2f081f06-9f42-473f-a0da-c39e5a28850d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBaebies
Version Model Number0975
Catalog Number0975
Company DUNS079264306
Company NameBAEBIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(844) 244-4034
Emailtechsupport@baebies.com
Phone(844) 244-4034
Emailtechsupport@baebies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819704020043 [Primary]

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-18

On-Brand Devices [Baebies]

00819704020210Quality Control Dried Blood Spot - Intermediate
00819704020067Quality Control Dried Blood Spot - High
00819704020050Quality Control Dried Blood Spot - Medium
00819704020043Quality Control Dried Blood Spot - Low
00819704020036Quality Control Dried Blood Spot - Base Pool

Trademark Results [Baebies]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BAEBIES
BAEBIES
86580936 5005262 Live/Registered
Baebies, Inc.
2015-03-30

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