FDA.reportPublic FDA data

SmartBx Spare parts

Primary DI
07290016936360
Brand
SmartBx Spare parts
Company
UC-CARE LTD
Model
FPRMC00031
Catalog number
FPRMC00031
Published
2026-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07290016936360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016936360072900169363607290016936360

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
649551124
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016936278SmartBxFPRMC00037FPRMC000372026-03-29
07290016936322Box of 80 SmartBx Disposable CassettesFPRPR00011FPRPR000112026-03-29
07290016936339Box of 10 SmartBx Disposable Needle CribsFPRPR00012FPRPR000122026-03-29
07290016936001Navigo™ Workstation FPRMC0016AFPRMC0016A2017-11-15
07290016936018Computer (Industrial)FPRCO00011FPRCO000112017-11-15
07290016936025Probe sensor assembly for BK 8808 (square)FPRSA00006FPRSA000062017-11-15
07290016936032Probe sensor assembly for BK 8818 and 8808e (square)FPRSA00007FPRSA000072017-11-15
07290016936049Probe sensor assembly for Hitachi V53W (square)FPRSA00008FPRSA000082017-11-15
07290016936056Probe sensor assembly for GE E8CS (square)FPRSA00009FPRSA000092017-11-15
07290016936063Probe sensor assembly for BK 8667 (square)FPRSA00011FPRSA000112017-11-15
07290016936070Probe sensor assembly for MindRayFPRSA00013FPRSA000132017-11-15
07290016936087Probe sensor assembly for GE E8CS FPRSA00014FPRSA000142017-11-15
07290016936094Probe sensor assembly for Hitachi V53W FPRSA00012FPRSA000122017-11-15
07290016936100Ascension transmitter Cubic AssemblyASMCH00034ASMCH000342017-11-15
07290016936117Roll Stand + Arm HRDGN00023HRDGN000232017-11-15
07290016936124Probe sensor assembly for EndoCareFPRSA00015FPRSA000152017-11-15
07290016936131Probe sensor assembly for D&K 8848FPRSA00016FPRSA000162017-11-15
07290016936148Probe sensor assembly for Civco 8848FPRSA00017FPRSA000172017-11-15
07290016936155Probe sensor assembly for Hitachi EUP-U533FPRSA00018FPRSA000182017-11-15
07290016936162Probe sensor assembly for GE BE9CSFPRSA00019FPRSA000192017-11-15

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
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