FDA.reportPublic FDA data

Hematology/Oncology Kit

Primary DI
00850070779142
Brand
Hematology/Oncology Kit
Company
Medzah Industries
Model
49721
Device description
Hematology/Oncology Kit
Published
2024-12-03
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
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850070779142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850070779142008500707791428500707791420850070779142

GMDN Terms#

Term, Definition table
TermDefinition
General specimen receptacle transport containerA non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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10194717120087Regard™ROI CPS, LLCOIB2024-10-02
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