FDA.reportPublic FDA data

LabChoice Midstream Specimen Catch Kit, Sterile

Primary DI
00840117338029
Brand
LabChoice Midstream Specimen Catch Kit, Sterile
Company
Dynarex Corporation
Model
43028
Device description
Content List: 4 oz Graduated Specimen Container, Protective Collar, Screw-on Lid, Patient Label, 3 BZK Towelettes, Instructions for use. STERILE-EO
Published
2025-03-14
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
OIEUrine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIEUrine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117329492PackageGS1100In Commercial Distribution
00840117338029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117329492008401173294928401173294920840117329492
00840117338029008401173380298401173380290840117338029

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784432120Cotton Tipped Plastic Applicators43212021-09-01
00616784432526Wooden Spoon, 3" (7.6 cm)43252026-04-27
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR362602022-05-17
00840117313385Resp-O2 Intubating Stylette, 6 Fr362652022-05-17
00840117313408Resp-O2 Intubating Stylette, 10 Fr362662022-05-17
00840117313422Resp-O2 Intubating Stylette, 12 Fr362672022-05-17
00840117315235Resp-O2 Intubating Stylette, 14 Fr362682022-05-17
00840117317451Resp-O2 Endotracheal Tube Cuffed, 4.0 mm362342024-10-24
00840117317468Resp-O2 Endotracheal Tube Cuffed, 4.5 mm362352024-10-24
00840117317482Resp-O2 Endotracheal Tube Cuffed, 5.5 mm362372024-10-24
00840117317499Resp-O2 Endotracheal Tube Cuffed, 6.0 mm362382024-10-24
00840117317505Resp-O2 Endotracheal Tube Cuffed, 6.5 mm362392024-10-24
00840117317512Resp-O2 Endotracheal Tube Cuffed, 7.0 mm362402024-10-24
00840117317529Resp-O2 Endotracheal Tube Cuffed, 7.5 mm362412024-10-24
00840117317536Resp-O2 Endotracheal Tube Cuffed, 8.0 mm362422024-10-24
00840117317543Resp-O2 Endotracheal Tube Cuffed, 8.5 mm362432024-10-24
00840117317550Resp-O2 Endotracheal Tube, Cuffed, 9.0 mm362442024-10-24
00840117318366Resp-O2 Durable Peak Flow Mouthpiece, With One-Way Valve, Adult361162021-04-22
00840117318373Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric361172021-04-22
00840117318380Resp-O2 Cardboard Peak Flow Mouthpieces, Disposable, Adult361182021-04-22

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