FDA.reportPublic FDA data

HanHeng

Primary DI
06973697810648
Brand
HanHeng
Company
Jiangsu HanHeng Medical Technology Co., Ltd
Model
C-042
Published
2022-11-14
Public version status
New
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
06973697810648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973697810648069736978106486973697810648

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
700447529
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
06973697811317 HanHengG-01292022-11-16
06973697811324 HanHengG-01302022-11-16
06973697811331 HanHengG-01312022-11-16
06973697811348 HanHengG-01322022-11-16
06973697811355 HanHengG-01332022-11-16
06973697811362 HanHengG-01342022-11-16
06973697811379 HanHengG-022022-11-16
06973697811386 HanHengG-0202022-11-16
06973697811393 HanHengG-0212022-11-16
06973697811409 HanHengG-0222022-11-16
06973697811416 HanHengG-032022-11-16
06973697811423 HanHengG-0302022-11-16
06973697811430 HanHengG-0312022-11-16
06973697811447 HanHengG-0322022-11-16
06973697811454 HanHengG-042022-11-16
06973697811461 HanHengG-0402022-11-16
06973697811478 HanHengG-0412022-11-16
06973697811485 HanHengG-0422022-11-16
06973697811492 HanHengG-052022-11-16
06973697811508 HanHengG-0502022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
58053326007021FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
10197344169214CARINGMEDLINE INDUSTRIES, INC.KXG2025-12-05
00840456216675JMUJMU DENTAL, INCKXG2025-11-12
00840456216682JMUJMU DENTAL, INCKXG2025-11-12
M220767003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
M220768013Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXG2025-09-11
00840456214916JMUJMU DENTAL, INCKXG2025-07-15
00840456214923JMUJMU DENTAL, INCKXG2025-07-15
58053326011653CLASSIQSwabCOPAN ITALIA SPAKXG2025-07-03
58053326011660CLASSIQSwabs™ FLOQ Swabs® COPAN ITALIA SPAKXG2025-07-03
00842558116402BactiSwab Dry PK/100REMEL, INC.KXG2025-06-19
00810180840958LabChoice Transport Swabs, Wooden Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00810180840965LabChoice Transport Swabs, Wooden Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00810180840972LabChoice Transport Swabs, Snappable Polystyrene Shaft, Cotton Tip, Sterile Dynarex CorporationKXG2025-02-28
00840117329706LabChoice Transport Swabs, Snappable Polystyrene Shaft, Viscose Tip, SterileDynarex CorporationKXG2025-02-28
00840165400372Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
00840165400396Starswab Dry SwabPretium Canada Packaging ULCKXG2025-02-21
05060166524524Oracol MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166525743Oracol SwabMALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
05060166524531Oracol+MALVERN MEDICAL DEVELOPMENTS LIMITEDKXG2024-12-19
58053326011684FLOQSwabs® COPAN ITALIA SPAKXG2024-12-18
00603266511848Super BrushSuper Brush, LLCKXG2024-08-30
10603266530839Super BrushSuper Brush, LLCKXG2024-08-30
10603266531874Super BrushSuper Brush, LLCKXG2024-08-30
10603266533830Super BrushSuper Brush, LLCKXG2024-08-30
10603266534875Super BrushSuper Brush, LLCKXG2024-08-30
10603266541835Super BrushSuper Brush, LLCKXG2024-08-30
00842558116501BactiSwab (Dry) CS/500Remel Inc.KXG2024-08-14
58053326011509FLOQSwabs® COPAN ITALIA SPAKXG2024-07-02