FDA.report

Tenovi

Primary DI
G004TCCLN010
Brand
Tenovi
Company
Tenovi Co.
Model
TC-CLN-01
Device description
Tenovi Cellular Glucometer Lancets
Published
2024-01-26
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

Product Codes

CodeName
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G004TCCLN010PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
127061577
Device count
1
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
false
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 DIBrandModelCatalogPublished
00850068074082TenoviTE-CPOG-A12026-01-14
00860008115997TenoviTE-BBPL-A12026-01-14
00850068074105TenoviTE-BPOG-A12026-01-07
00850068074402TenoviTE-BBPL-C12026-01-05
00850068074174TenoviTE-KBGZ-A12026-01-02
00850068074181TenoviTE-CBPL-B12026-01-02
00850068074211TenoviTE-CBPH-B12026-01-02
00850068074228TenoviTE-KPBG-A22026-01-02
00850068074266TenoviTE-CBGZ-A12026-01-02
00850068074365TenoviTE-BBPS-B12026-01-02
00850068074518TenoviTE-BFDG-A12025-11-24
00850068074310TenoviTE-BSCW-A12025-11-20
00850068074389TenoviTE-CSCW-A12025-11-20
00850068074457TenoviTE-BBGZ-B12025-11-20
00850068074471TenoviTE-BSCR-B12025-11-20
00850068074020TenoviTE-BPBG-A12025-09-08
00085006807402TenoviTE-BPBG-A12025-08-29
00850068074006TenoviTE-BTMI-A12025-08-29
00850068074525TenoviTE-BPBG-B12025-08-29
G004TCCBP010TenoviTC-CBP-012024-01-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
40301936020215MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
40301936021212MICROLET® NEXTASCENSIA DIABETES CARE US INC.QRK2026-03-16
36945630142018STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
36945630142025STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
36945630142032STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
36945630142049STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
36945630142063STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-03-09
20197344174437CARINGMEDLINE INDUSTRIES, INC.QRK2026-03-03
10682607541055On Call Lancets 30GAcon Laboratories, Inc.QRK2026-02-19
00810079240579Teladoc Health, Inc.Teladoc Health, Inc.QRK2026-02-17
06949517006201N/MShandong Lianfa Medical Plastic Products CO.,LTDQRK2026-01-31
36945630141295STERiLANCESterilance Medical (Suzhou) Inc.QRK2026-01-02
36945630141301SinocareSterilance Medical (Suzhou) Inc.QRK2026-01-02
36945630141288STERiLANCESterilance Medical (Suzhou) Inc.QRK2025-12-31
06949517009462N/MShandong Lianfa Medical Plastic Products CO.,LTDQRK2025-12-10
00850015109058Active ForwardOWELLQRK2025-12-02
00850044855346OWELLOWELLQRK2025-12-02
00850044855353OWELLOWELLQRK2025-12-02
00850044855360OWELLOWELLQRK2025-12-02
00850044855377OWELLOWELLQRK2025-12-02
00850044855421OWELLOWELLQRK2025-12-02
00850044855476OWELLOWELLQRK2025-12-02
10383568101134EasyLife Blood Lancet 30G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
10383568101141EasyLife Blood Lancet 31G 100pcsCare Living Diagnostics Inc.QRK2025-09-17
06949517009028One +StepShandong Lianfa Medical Plastic Products CO.,LTDQRK2025-09-14
MHC18281010EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-08-04
MHC18301010EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-08-04
MHC18303010EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-08-04
MHC18321010EasyTouchMHC MEDICAL PRODUCTS, LLCQRK2025-08-04
36945630136673suttersyncSterilance Medical (Suzhou) Inc.QRK2025-05-23