FDA.reportPublic FDA data

Specimen Collection Swab

Primary DI
08809262394153
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
08809262394153PrimaryGS10
08809262394108Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262394153088092623941538809262394153
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
+82448629134hlbhc@hlbbio.co.kr

Regulatory Flags#

DUNS number
987587913
Device count
20
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
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
08809262394139Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen 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