babyLance

GUDID 10814247020120

Preemie (Pink/White) 0.85 mm depth, Safety Heelstick

CLINICAL INNOVATIONS, LLC

Manual blood lancing device, single-use
Primary Device ID10814247020120
NIH Device Record Keyf047d920-3225-473e-8751-341607a21c18
Commercial Distribution StatusIn Commercial Distribution
Brand NamebabyLance
Version Model NumberBLP
Company DUNS809524291
Company NameCLINICAL INNOVATIONS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814247020123 [Primary]
GS110814247020120 [Package]
Contains: 00814247020123
Package: [50 Units]
In Commercial Distribution
GS120814247020127 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-24
Device Publish Date2023-04-14

On-Brand Devices [babyLance]

10814247020182Newborn (Blue/Green) 1.0 mm depth, Safety Heelstick
10814247020168Micropreemie (Yellow/Green) 0.60 mm depth, Safety Heelstick
10814247020120Preemie (Pink/White) 0.85 mm depth, Safety Heelstick

Trademark Results [babyLance]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BABYLANCE
BABYLANCE
79086209 3964587 Live/Registered
Clinical Innovations, LLC
2010-06-24
BABYLANCE
BABYLANCE
79080935 3857040 Live/Registered
Clinical Innovations, LLC
2010-02-19

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