FDA.reportPublic FDA data

Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count

Primary DI
00894046001875
Brand
Advocate Redi-Code+ Test Strips for Blood Glucose 35 Count
Company
DIABETIC SUPPLY OF SUNCOAST, INC.
Model
BMB002-35
Catalog number
BMB002-35
Device description
Advocate Redi-Code+ Test Strips for accurate monitoring of blood glucose levels 35 Count
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20894046001879PackageGS1400In Commercial Distribution
30894046001876PackageGS120In Commercial Distribution
00894046001875PrimaryGS10
40894046001873Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089404600187920894046001879
3089404600187630894046001876
00894046001875008940460018758940460018750894046001875
4089404600187340894046001873

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature39.2 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-866-373-2824info@pharmasupply.com

Regulatory Flags#

DUNS number
043081723
Device count
35
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894046001578Advocate Redi- Code+ Test Strips for Blood Glucose 50 CountBMB002BMB0022016-08-19
00894046001394Advocate Redi-Code+ Pharmacy Test Strips BMB002-PBMB002-P2016-08-19
00852982006491Advocate Redi-Code+ Test Strips for Blood Glucose 10 countBMB002-10BMB002-102018-03-27
00852982006415ADVOCATE Heating Pad International327-INTLJY65002020-07-10
00894046001141ADVOCATE HEATING PAD KING SIZE315JY61012017-03-10
00894046001554ADVOCATE HEATING PAD CLASSIC SIZE327JY61002017-03-10
00852982006354ADVOCATE ORAL & RECTAL THERMOMETER1451452017-02-06
00894046001042Advocate Non-Contact Infra-red thermometer1401402016-08-22
00894046001516Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual403-FG403-FG2016-08-22
00894046001400Advocate Arm BPM S/M CUFF406 S/M406 S/M2016-08-22
00894046001417Advocate Arm BPM L Cuff406L406L2016-08-22
00894046001509American Heart- Tech Non-Speaking Wrist BPMKD-735405-HT2016-08-22
00894046001530Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff406XL406XL2016-08-22
00852982006408Advocate Blood Pressure Monitor Non-Speaking Wrist FT-B05WFT-B05W2017-04-17
00894046001097Advocate Lancets Twist Top 30 Gauge3082020-06-22
00894046001899Advocate Lancets Safety 21 Gauge 2.4mm6342020-06-22
00894046001905Advocate Lancets Safety 23 Gauge6352020-06-22
00894046001912Advocate Lancets Safety 28 Gauge6372020-06-22
00894046001929Advocate Lancets Safety 26 G 1.8 mm6362020-06-22
00852982006132Advocate Pen Needle 31G 6MM 6436432016-12-12

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