FDA.reportPublic FDA data

Specimen Collection Swab

Primary DI
08809262394139
Brand
Specimen Collection Swab
Company
HLB CO.,LTD
Model
FASPS02
Published
2025-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809262394139PrimaryGS10
08809262394108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262394139088092623941398809262394139
08809262394108088092623941088809262394108

GMDN Terms#

Term, Definition table
TermDefinition
Oral/upper respiratory tract specimen collection swabA piece of absorbent or non-absorbent material, with no additives, detached or on a stick, and intended to be used by a healthcare professional for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for culture, analysis, and/or other investigation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+448629134hlbhc@hlbbio.co.kr

Regulatory Flags#

DUNS number
987587913
Device count
60
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809262391039Specimen Collection SwabFANAB012025-10-28
08809262391053Specimen Collection SwabFANTK012025-10-28
08809262391060Specimen Collection SwabFASPS022025-10-28
08809262391077Specimen Collection SwabFASPS102025-10-28
08809262391329Specimen Collection SwabFANAB012025-10-28
08809262391336Specimen Collection SwabFASPS022025-10-28
08809262391343Specimen Collection SwabFASPS022025-10-28
08809262391350Specimen Collection SwabFASPS022025-10-28
08809262391367Specimen Collection SwabFASPS022025-10-28
08809262391374Specimen Collection SwabFASPS102025-10-28
08809262391527Specimen Collection SwabFASPS102025-10-28
08809262391534Specimen Collection SwabFASPS102025-10-28
08809262392104Specimen Collection SwabFAPPP012025-10-28
08809262394030Specimen Collection SwabFANAB012025-10-28
08809262394047Specimen Collection SwabFANAB012025-10-28
08809262394061Specimen Collection SwabFASPS102025-10-28
08809262394078Specimen Collection SwabFASPS102025-10-28
08809262394085Specimen Collection SwabFASPS102025-10-28
08809262394092Specimen Collection SwabFASPS102025-10-28
08809262394115Specimen Collection SwabFASPS022025-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391343Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391350Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391367Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391374Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391527Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391534Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262392104Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394030Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394047Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394061Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394078Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394085Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394092Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394115Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394122Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394153Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394177Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394191Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394207Specimen Collection swabHLB CO.,LTDKXG2025-10-28
08809262394214Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394221Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394238Specimen Collection SwabHLB CO.,LTDKXG2025-10-28