FDA.report

owell

Primary DI
00850015109010
Brand
owell
Company
O'well
Model
OW-BL-30g-300
Published
2020-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

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
00850015109010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015109010008500151090108500151090100850015109010

GMDN Terms

TermDefinition
Blood glucose/blood pressure monitoring system, home-useA collection of devices intended for the quantitative measurement of glucose levels in whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Sterilization Methods

Method

Regulatory Flags

DUNS number
052943257
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850015109003owellOW-BL-33g-3002020-01-20
00850015109027owellOW-BL-28g-300 2020-01-20
00850015109034owellOW-BL-26g-3002020-01-20
00860167002510owellOW-BL-26g-1002019-10-11
00860167002527owellOW-BL-28g-100 2019-10-11
00860167002534owellOW-BL-30g-100 2019-10-11
00860167002541owellOW-BL-33g-1002019-10-11
00860167002558owellOW-BL-26g-50 2019-10-11
00860167002565owellOW-BL-28g-502019-10-11
00860167002572owellOW-BL-30g-50 2019-10-11
00860167002589owellOW-BL-33g-502019-10-11
00860167002596owellOW-LD+40L2019-10-11
00860167002503OwellMED-OW-A100-KIT-502018-10-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
26931918108718AllesetGRI Medical & Electronic Technology Co., Ltd.FMK2026-03-16
36945630141981STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
06945630141997STERiLANCESterilance Medical (Suzhou) Inc.FMK2026-03-09
30885632507070MedichoiceOWENS & MINOR DISTRIBUTION, INC.FMK2026-02-17
00843484108356Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
00843484108370Ever Ready First AidSZY HOLDINGS, LLCFMK2026-02-13
10848530107557DiabeticsSUNSET HEALTHCARE SOLUTIONS, INC.FMK2025-12-19
04719893237139TD-5052 AKTIVSAFE LANCET (Sterile) (21G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237153TD-5052 AKTIVSAFE LANCET (Sterile) (26G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
04719893237177TD-5052 AKTIVSAFE LANCET (Sterile) (30G) (100PCS/BOX)TAIDOC TECHNOLOGY CORPORATIONFMK2025-11-25
01850011833123VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833192VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833215VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833222VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833284VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833291VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833307VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833314VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833338VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833352VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833369VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833376VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833383VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833390VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833406VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833413VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833451VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833468VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833512VerifinePromisemed Medical Devices Inc.FMK2025-11-20
01850011833819VerifinePromisemed Medical Devices Inc.FMK2025-11-20