Home GUDID 00894030002086 Embrace Strips, 10-ct
Primary DI 00894030002086
Brand Embrace Strips, 10-ct
Company OMNIS HEALTH
Model APX02AB0200
Published 2016-08-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Single use true Product Codes# Code, Name table Code Name LFR Glucose Dehydrogenase, Glucose
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LFR Glucose Dehydrogenase, Glucose Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00894030002086 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00894030002086 00894030002086 894030002086 0894030002086
GMDN Terms# Term, Definition table Term Definition Home-use/point-of-care blood glucose monitoring system IVD A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used together for testing, either at the point-of-care or self-testing by a layperson, for the quantitative measurement of glucose in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Regulatory Flags# DUNS number 023891520 Device count 1 Lot or batch true Serial number true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00894030002345 Embrace EVO Control Solution, L1 (Low) APX02AB0810 2016-08-23 00894030002352 Embrace EVO Strips, 50ct Vial - RETAIL APX02AB0802 2016-08-23 00894030002376 Embrace EVO Control Solution, L2 (Medium) APX02AB0811 2016-08-23 00894030002390 Embrace Pro Meter ALL01AB0200 2016-08-23 00894030002406 Embrace Pro Strips, 50-ct vials ALL02AB0202 2016-08-23 00894030002413 Embrace Pro Control Solution (L1/Normal; L2/High) ALL02AB0210 2016-08-23 00894030002420 Embrace EVO Mini Meter, all-in-one kit, RETAIL APX01AB0851 2016-08-23 00894030002475 EmbraceEVO Gestational Diabetes Package - SMALL (5 vials) APX01GS0100-S 2016-08-23 00894030002482 EmbraceEVO Gestational Diabetes Package - LARGE (9 vials) APX01GS0100-L 2016-08-23 00894030002543 EmbraceEVO Gestational Diabetes Package - RETAIL (5 vials) APX01AGS0100-SR 2016-08-23 00894030002017 Embrace Meter, Meter Only APX01AB200 2016-08-23 00894030002024 Embrace Strips, 50ct Vial - Distributor partner APX02AB0202 2016-08-23 00894030002062 Embrace Control Solution, L2 (High) APX02AB0311 2016-08-23 00894030002079 Embrace Control Solution, L1 (Low) APX02AB310 2016-08-23 00894030002260 Embrace Meter Kit (w/10 ct) APX01AB0300 2016-08-23 00894030002338 Embrace Strips, 50ct Vial - Mail Order (Yellow Band) APX02AB0202MO 2016-08-23 00894030002536 Embrace Meter Value Pack (incl. 50ct) APX01AK0200VK 2016-08-23 00894030002550 Embrace Gestational Diabetes Package - SMALL (5 vials) APX01GS0200-S 2016-08-23 00894030002567 Embrace Gestational Diabetes Package - LARGE (9 vials) APX01GS0200-L 2016-08-23 00894030002574 Embrace Gestational Diabetes - Strips Refill Bundle (4 vials) APX02GS0202RF 2016-08-23
Other Devices Sharing Product Codes#