FDA.reportPublic FDA data

Prevantics® Device Swab

Primary DI
10310819001523
Brand
Prevantics® Device Swab
Company
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Model
B19600
Catalog number
B19600
Device description
Pre-moistened swab to disinfect needleless access sites prior to use.
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10310819001523PackageGS1100In Commercial Distribution
00310819001526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031081900152310310819001523
00310819001526003108190015263108190015260310819001526

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
00310819001779Prevantics® Device Swab StripB123STB123ST2020-08-03

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