Pure Comfort Twist Top Lancets 30G

GUDID 10860003125554

• 30 Gauge • Twist top lancets • Single use • Provides virtually painless testing • Comfort depth penetration • Smooth tri-bevel point • 100 sterile tip lancets per box

HOME AIDE DIAGNOSTICS, INC.

Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use Manual blood lancing device, single-use
Primary Device ID10860003125554
NIH Device Record Key00ab66c7-e208-47cd-83ea-faf37ff21d44
Commercial Distribution StatusIn Commercial Distribution
Brand NamePure Comfort Twist Top Lancets 30G
Version Model NumberPureCTT30
Company DUNS783518983
Company NameHOME AIDE DIAGNOSTICS, 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us
Phone18009150116
Emailinfo@homeaide.us

Device Dimensions

Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge
Needle Gauge30 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003125557 [Primary]
GS110860003125554 [Package]
Contains: 00860003125557
Package: Case [200 Units]
In Commercial Distribution

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-04
Device Publish Date2020-01-27

On-Brand Devices [Pure Comfort Twist Top Lancets 30G]

10860003125554• 30 Gauge • Twist top lancets • Single use • Provides virtually painless testing �
10860003125561One handed use No lancing device required Automatic needle retraction Lock out after use prevent

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.