FDA.report

Pro Comfort Twist Top Lancets 30G

Primary DI
10850632007017
Brand
Pro Comfort Twist Top Lancets 30G
Company
HOME AIDE DIAGNOSTICS, INC.
Model
7010
Device description
• 30 Gauge • Twist top lancets • Single use • Provides virtually painless testing • Comfort depth penetration • Smooth tri-bevel point • 100 sterile tip lancets per box
Published
2018-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMKLancet, Blood

Product Code Classifications

CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850632007017PackageGS1200In Commercial Distribution
00850632007010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085063200701710850632007017
00850632007010008506320070108506320070100850632007010

GMDN Terms

TermDefinition
Manual blood lancing device, single-useA sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.

Device Sizes

TypeValueUnit
Needle Gauge30Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
18009150116info@homeaide.us

Regulatory Flags

DUNS number
783518983
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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