FDA.reportPublic FDA data

Prevantics® Device Swab Strip

Primary DI
00310819001779
Brand
Prevantics® Device Swab Strip
Company
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Model
B123ST
Catalog number
B123ST
Device description
Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LKBPad, Alcohol, Device Disinfectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKBPad, Alcohol, Device DisinfectantUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132380000PREVANTICS DEVICE SWABProfessional Disposables International, Inc.2014-08-27LKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10310819001776PackageGS1160In Commercial Distribution
00310819001779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031081900177610310819001776
00310819001779003108190017793108190017790310819001779

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning/disinfection wipeA moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.034Fluid Ounce

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-999-6423pdicustomercare@pdihc.com

Regulatory Flags#

DUNS number
800777117
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310819000031Prevantics® Device Large Swab C71200C712002024-02-15
00310819000482PDI® Lubricating Jelly IIT00137T001372020-10-09
00310819000499PDI® Lubricating Jelly IIT00250T002502020-10-09
00310819000475PDI® Electrode Prep PadB59800B598002020-08-03
00310819000307Hygea Sterile Saline WipeC22370C223702020-08-03
00310819000451PDI® Adhesive Tape Remover PadB16400B164002020-08-03
00310819001526Prevantics® Device Swab B19600B196002020-08-03
10310819000304Hygea Sterile Saline WipeC22370C223702020-08-03
10310819000458PDI® Adhesive Tape Remover PadB16400B164002020-08-03
10310819000472PDI® Electrode Prep PadB59800B598002020-08-03
10310819001523Prevantics® Device Swab B19600B196002020-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253047088WebcolCardinal Health 200, LLCLKB2025-10-16
10192253045741WebcolCardinal Health 200, LLCLKB2025-09-29
50192253045749WebcolCardinal Health 200, LLCLKB2025-09-29
10192253047073WebcolCardinal Health 200, LLCLKB2025-07-28
50192253047071WebcolCardinal Health 200, LLCLKB2025-07-28
50192253045725WebcolCardinal Health 200, LLCLKB2025-06-12
10192253045727WebcolCardinal Health 200, LLCLKB2025-06-12
10192253047066WebcolCardinal Health 200, LLCLKB2025-06-10
20192253047063WebcolCardinal Health 200, LLCLKB2025-06-10
00860000526517True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10860000526514True Comfort Alcohol PadsHOME AIDE DIAGNOSTICS, INC.LKB2024-10-08
10192253046205WebcolCardinal Health 200, LLCLKB2024-09-05
10653160373858MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00653160373851MEDLINEMEDLINE INDUSTRIES, INC.LKB2024-04-25
00310819000031Prevantics® Device Large Swab PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.LKB2024-02-15
10850049784532SURGYCOSurgyco LLCLKB2023-12-15
10850049784556SURGYCOSurgyco LLCLKB2023-12-15
20850049784539SURGYCOSurgyco LLCLKB2023-12-15
20850049784553SURGYCOSurgyco LLCLKB2023-12-15
10801741086936SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
10801741086943SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086939SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
00801741086946SITE-SCRUBBard Access Systems, Inc.LKB2023-12-13
50192253047095WebcolCardinal Health 200, LLCLKB2023-10-09
10192253047097WebcolCardinal Health 200, LLCLKB2023-10-09
00326053104770Regard™Resource Optimization & Innovation, L.L.C.LKB2023-08-08
06972403307571ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
06972403307564ZDXuchang Zhende Surgical Dressing Co., Ltd.LKB2023-06-28
00810132040788HCSConcordance Healthcare Solutions LLCLKB2023-05-01
00810132040795HCSConcordance Healthcare Solutions LLCLKB2023-05-01