FDA.reportPublic FDA data

AgaMatrix

Primary DI
20385541833015
Brand
AgaMatrix
Company
AgaMatrix, Inc.
Model
8000-01833
Catalog number
N/A
Device description
Lancets, AgaMatrix, 100CT, 28Gauge
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20385541833015PackageGS120In Commercial Distribution
30385541833012PackageGS110In Commercial Distribution
00385541833011PrimaryGS10
80385541833017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2038554183301520385541833015
3038554183301230385541833012
00385541833011003855418330113855418330110385541833011
8038554183301780385541833017

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancing device tipA sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-906-4197customerservice@agamatrix.com

Regulatory Flags#

DUNS number
156756129
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10385540109732CareSens S Fit BT8000-109732025-11-30
10385540109749CareSens S8000-109742025-08-04
00385540109728CareSens S Fit8000-109722025-08-04
00385540109759CareSens S8000-109752025-08-04
00385540132504AgaMatrix Lancing Device8300-013252023-09-18
00385541062206AgaMatrix Lancing Device8300-106222023-09-18
10385541001509AgaMatrix8000-033902016-11-04
10385541003305AgaMatrix8000-105192016-11-04
10385541003503AgaMatrix8000-105202016-11-04
10385542013013AgaMatrix8000-020132016-11-04
10385543334018AgaMatrix8000-033342016-11-04
10385544034016AgaMatrix8000-040342016-11-04
00385541000802AgaMatrix8000-040882016-11-04
00385541001908AgaMatrix8000-104742016-07-11
00385541002103AgaMatrix8000-104732016-07-11
00385541002608AgaMatrix8000-104712016-07-11
00385541833011AgaMatrix8000-01833N/A2023-01-06
00385541971010AgaMatrix8000-01971N/A2023-01-06
00385542649017AgaMatrix8000-026492016-11-04
00385543764023AgaMatrix8000-037642016-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786890True IntegralTRUE INTEGRAL INCQRK2026-05-28
00860015970701True IntegralTRUE INTEGRAL INCQRK2026-05-27
00860015786838True IntegralTRUE INTEGRAL INCQRK2026-05-20
00810011730694GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-09
00850080988428AUVONUAN HEALTHCARE LIMITEDQRK2026-05-09
00810011730687GoodLifeTianjin Huahong Technology Co., Ltd.QRK2026-05-06
00860015383969True IntegralTRUE INTEGRAL INCQRK2026-04-14
00682607541072On Call Lancets (33G)Acon Laboratories, Inc.QRK2026-03-30
00301936020217MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
00301936021214MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
16945630142014STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142021STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142038STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142045STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
16945630142069STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
00197344174433CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
00850080988107AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00850080988114AUVONUAN HEALTHCARE LIMITEDQRK2026-03-02
00682607541058On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240586Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00810079240609Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
00850080988091AUVONUAN HEALTHCARE LIMITEDQRK2026-02-06
16945630141291STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141307SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
16945630141284STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
00810011730649HuahongTianjin Huahong Technology Co., Ltd.QRK2025-12-24
MHC1826101EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-11-10
20197344111838MEDLINEMEDLINE INDUSTRIES, INC.QRK2025-10-22
00383568101137EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
00383568101144EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17