FDA.reportPublic FDA data

Medzah eGFR Collection Kit

Primary DI
20860013131214
Brand
Medzah eGFR Collection Kit
Company
Medzah Industries
Model
MDZHEGFR01
Device description
Medzah eGFR Collection Kit
Published
2024-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20860013131214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2086001313121420860013131214

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
114193536
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011917486MEDZAH INSTANT HOT PACKSAM-20002025-07-30
10860012637406MEDZAH INSTANT HOT PACKSAM-20012025-07-30
10860012637413Instant Cold Pack 4.75x7SAM-30002025-08-11
10860012637420Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
00860010472149Instant Cold Pack 6inx9inSAM-10012025-08-11
10860011820168MEDISERVEMSMD012024-07-22
10860011820175MEDISERVEMSMD022024-07-22
10860011820182MEDISERVEMSMD032024-07-22
10860011820199MEDISERVEMSMD042024-07-22
10860011916601MEDISERVEMSMD052024-07-22
10860010472146Instant Cold Pack 6inx9inSAM-10012025-08-11
20860012637410Instant Cold Pack 4.75x7SAM-30002025-08-11
20860012637427Non-Woven Instant Cold Packs 5in x 7.5inSAM-30012025-08-11
10860011343872BIONEXBNMD012025-07-30
10860011343889BIONEXBNMD022025-07-30
10860011343896BIONEXBNMD032025-07-30
10860011725401BIONEXBNMD042025-07-30
10860011725418BIONEXBNMD052025-07-30
10860011917493MEDZAH INFANT HEEL WARMERSAM-1082025-07-30
20860011343879BIONEXBNMD012025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380008761CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380008785CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380036467CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380073714CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380084451CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
20885380169004CARDINAL HEALTHCardinal Health 200, LLCNNK2026-08-22
00810111410861LetsGetChecked Stool Sample Collection Kit (FCIT)PRIVAPATH DIAGNOSTICS LIMITEDNNK2026-08-07
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17