FDA.reportPublic FDA data

Medline

Primary DI
20888277409184
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPH4560
Catalog number
MPH4560
Device description
CONTROL,EVENCARE PRO, HI LO
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111456000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111456000MEDISIGN BLOOD GLUCOSE MONITORING SYSTEMTianjin Empecs Medical Device Co., Ltd.2012-02-28NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20888277409184PackageGS16In Commercial Distribution
10888277409187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088827740918420888277409184
1088827740918710888277409187

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight, Protect from freezing, avoid excessive heat

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

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Primary DI, Brand, Company table
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04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
05700693930978ABL90 FLEXRadiometer Medical ApSCGA2026-07-09
05700693930985ABL90 FLEX PLUSRadiometer Medical ApSCGA2026-07-09
05700699446572SP90Radiometer Medical ApSCGA2026-07-09
05700699447579SP90Radiometer Medical ApSCGA2026-07-09
05700699461056SC90Radiometer Medical ApSCGA2026-07-09
05700699461087SC90Radiometer Medical ApSCGA2026-07-09
05700699461094SC90Radiometer Medical ApSCGA2026-07-09
05700699461100SC90Radiometer Medical ApSCGA2026-07-09
05700699461131SC90Radiometer Medical ApSCGA2026-07-09
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MHC1101665142EasyTouchMHC MEDICAL PRODUCTS, LLCCGA2026-01-07
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00311917064635WalgreensWALGREEN CO.CGA2025-06-20
00353885013000OneTouch UltraLifeScan U.S. LLCCGA2025-06-20
00194346219254ReliOn™ Premier Blood Glucose Test StripsWAL-MART STORES, INC.CGA2025-02-11
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00054749005710i-STAT G CartridgeABBOTT POINT OF CARE INC.CGA2024-04-30
00381932488013Assy Vial, eGLU, 13 ct.POLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-07-30
MHC19902833042Members MarkWAL-MART STORES, INC.CGA2023-05-10
MHC19902833062Members MarkWAL-MART STORES, INC.CGA2023-04-18
MHC19902833072Members MarkWAL-MART STORES, INC.CGA2023-04-18
00381934748016Assy Vial, eGLU Test Strips, 15 ct, CardioChek Plus HomePOLYMER TECHNOLOGY SYSTEMS, INC.CGA2023-03-25
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24