FDA.reportPublic FDA data

Cultura™

Primary DI
20884450491106
Brand
Cultura™
Company
Merit Medical Systems, Inc.
Model
00884450491102
Catalog number
C100F
Published
2020-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
10884450491109PackageGS125In Commercial Distribution
20884450491106PackageGS14In Commercial Distribution
00884450491102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445049110910884450491109
2088445049110620884450491106
00884450491102008844504911028844504911020884450491102

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal swabA device designed as a piece of absorbent material, with no additives, on a stick and intended to be used for the collection, and preservation and/or transport, of a clinical specimen from the nasopharynx for culture, analysis, and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184763290
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450376867Merit Medical®Initial ReleaseK09-10502F2026-09-26
00884450431597Merit Medical®Initial ReleaseK09-12862A2026-09-26
00884450432105Merit Medical®Initial ReleaseK09-08926B2026-09-26
00884450707104Merit Medical®DTS1202026-09-26
00884450707111Merit Medical®DTS2202026-09-26
00884450028605Merit Medical®Initial ReleaseK08-01254A2026-09-24
00884450277652Safety Paracentesis Procedure TrayInitial ReleaseSPPT-8F-10S2026-09-22
00884450416723SureCrossDSC18652026-09-22
00884450422755SureCrossDSC14902026-09-22
00884450423110SureCrossDSC14652026-09-22
00884450427170SureCrossDSC141352026-09-22
00884450428016Merit Medical®Initial ReleaseK10-03360H2026-09-22
00884450435526Merit Medical®Initial ReleaseK09-11159A2026-09-22
00884450445419Merit Medical®Initial ReleaseK09-01589X2026-09-22
00884450473313Merit Medical®Initial ReleaseK09-14357A2026-09-22
00884450852279Merit Medical®Initial ReleasePC8112026-09-22
00884450852286Merit Medical®Initial ReleasePC8122026-09-22
10884450489809Prelude SNAP™APLSX-25112026-09-22
10884450489816Prelude SNAP™APLSS-10062026-09-22
10884450489823Prelude SNAP™APLSS-10072026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971893320473Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
06971893320794Disposable Sampling SwabMIRACLEAN TECHNOLOGY CO., LTD.KXG2026-08-26
00609576381164Puritan®Puritan Medical ProductsKXG2026-07-31
10609576901789QuickVuePuritan Medical ProductsKXG2026-07-31
30609576380618Hospital®Puritan Medical ProductsKXG2026-07-31
00609576381119Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381133Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381423Puritan®Puritan Medical ProductsKXG2026-07-27
00609576381676Puritan®Puritan Medical ProductsKXG2026-07-27
00609576901799Puritan®Puritan Medical ProductsKXG2026-07-27
30609576381196Puritan®Puritan Medical ProductsKXG2026-07-27
30609576380601Hospital®Puritan Medical ProductsKXG2026-07-20
30609576380809Puritan®Puritan Medical ProductsKXG2026-07-20
50609576901701cobas Dual SwabsPuritan Medical ProductsKXG2026-07-20
00810124537616VaklyAvaline Medical NJ Limited Liability CompanyKXG2026-07-16
00609576010132BD AffirmPuritan Medical ProductsKXG2026-07-08
00609576381539Puritan®Puritan Medical ProductsKXG2026-07-08
00609576381782Puritan®Puritan Medical ProductsKXG2026-07-08
00609576390302Puritan®Puritan Medical ProductsKXG2026-07-08
10609576380362Puritan®Puritan Medical ProductsKXG2026-07-08
10609576381413Puritan®Puritan Medical ProductsKXG2026-07-08
00884999051737RealTimeABBOTT MOLECULAR INC.KXG2026-07-06
00884999051744Alinity mABBOTT MOLECULAR INC.KXG2026-07-06
00609576010378BD ProbeTecPuritan Medical ProductsKXG2026-07-02
00609576390142PuritanPuritan Medical ProductsKXG2026-07-02
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
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