FDA.report

MNG Buccal Swab

Primary DI
00850070779081
Company
Medzah Industries
Model
125222
Device description
MNG Buccal Swab
Published
2024-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
114193536
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00850070779081PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00850070779081PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
NNKContainer, Specimen Mailer And Storage, Non-Sterile1Pathology864.3250NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
20860011343879BIONEXBNMD012025-07-30
20860011343886BIONEXBNMD022025-07-30
20860011343893BIONEXBNMD032025-07-30
20860011725408BIONEXBNMD042025-07-30
20860011725415BIONEXBNMD052025-07-30
20860011917483MEDZAH INSTANT HOT PACKSAM-20002025-07-30
20860011917490MEDZAH INFANT HEEL WARMERSAM-1082025-07-30
20860012637403MEDZAH INSTANT HOT PACKSAM-20012025-07-30
00860009922730Medzah Steel Walkers with 5" WheelsMDZH904SE2025-03-07
00860009784895Ditek Urine Collection CupCP102212025-03-06
00860012637430SnapnSealEVON1022025-03-06
00850070779050MNG 5-Tube CSF Collection1252182024-12-03
00850070779067MNG TRIO Blood Testing1252202024-12-03
00850070779074MNG Single Blood Genetic Test1252212024-12-03
00850070779098MNG Blood Enzymology Testing1252232024-12-03
00850070779104MNG - PTC Collection Kit1337192024-12-03
00850070779111MNG - RNA Sequencing Collection Kit1389572024-12-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
30860013988020500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
30860013988037500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
20860013988047Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
30860013988051Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
10860013988064Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
10860013988071Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988081Advance Dx Blood Collection Card: Triple-Single Strip cardsADVANCE DX, INC.NNK2026-03-03
10860013988095Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
B24280EZDEV21000Unfilled Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2026-02-02
80827989007778Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
80827989007792Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00859410006351SalimetricsSALIMETRICS, LLCNNK2025-12-10
00859410006368SalimetricsSALIMETRICS, LLCNNK2025-12-10
06975025177478BabioJinan Babio Biotechnology Co., Ltd.NNK2025-09-29
040669160437422.0ml SC Micro Tube protein LBSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
04066916044534SCMTube 0,5 mlSarstedt Aktiengesellschaft & Co.KGNNK2025-09-25
50810010894897Aero-MedAERO-MED, LLCNNK2025-09-11
00860013988005Advance Dx 100 Blood Collection CardADVANCE DX, INC.NNK2025-08-28
00860013988012Blood Specimen Return BagADVANCE DX, INC.NNK2025-08-28
50810010894750Aero-MedAERO-MED, LLCNNK2025-08-13
50810010894767Aero-MedAERO-MED, LLCNNK2025-08-13
00810185250011TherapakTherapak LLCNNK2025-08-11
00810185250219TherapakTherapak LLCNNK2025-08-11
00810185250356TherapakTherapak LLCNNK2025-08-11
00810185250615TherapakTherapak LLCNNK2025-08-11
00810185250653TherapakTherapak LLCNNK2025-08-11
00810185250578TherapakTherapak LLCNNK2025-08-04
00810185250059TherapakTherapak LLCNNK2025-08-04
G669CNBOX1CNS0Crow's Nest Biopsy Catchment SystemCorramedical Inc.NNK2025-07-09
G669CNBOX4CNS1Crow's Nest Biopsy Catchment SystemCorramedical Inc.NNK2025-07-09