FDA.reportPublic FDA data

Advocate BMB Control Solutions High

Primary DI
00894046001608
Brand
Advocate BMB Control Solutions High
Company
DIABETIC SUPPLY OF SUNCOAST, INC.
Model
005
Catalog number
005
Device description
Advocate BMB Control Solutions High
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
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20894046001602PackageGS11000In Commercial Distribution
00894046001608PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2089404600160220894046001602
00894046001608008940460016088940460016080894046001608

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8884693579lhenry@pharmasupply.com

Regulatory Flags#

DUNS number
043081723
Device count
1
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
00894046001875Advocate Redi-Code+ Test Strips for Blood Glucose 35 CountBMB002-35BMB002-352016-08-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
10758750035380VITROSORTHO CLINICAL DIAGNOSTICSJJX2025-05-20
10758750035076VITROSORTHO CLINICAL DIAGNOSTICSJJX2024-09-18
00021292015091TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00021292015107TRUENESSTRIVIDIA HEALTH, INC.JJX2024-04-03
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSJJX2022-08-09
00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
14987481164441uTASWako AFP-L3 Control LFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23
14987481164458uTASWako AFP-L3 Control HFUJIFILM WAKO PURE CHEMICAL CORPORATIONJJX2020-10-23