BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Prevantics® Device Swab Strip

DI: 00310819001779 · Model: B123ST · PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Prevantics® Device Swab Strip
Primary DI: 00310819001779
Version / Model: B123ST
Catalog Number: B123ST
Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Labeler DUNS: 800777117
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-08-03
Public Version: 1
Public Version Date: 2020-08-11
Public Version Status: New
Public Device Record Key: dd417768-f15d-44b1-9acc-a2eda28f394a

Device Description

Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs.

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: No
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKB	Pad, Alcohol, Device Disinfectant	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58077	Medical device cleaning/disinfection wipe	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310819001779	GS1
Package	10310819001776	GS1	box	160	In Commercial Distribution

Customer Contacts

Phone: 800-999-6423
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132380	000

Device Sizes

Type	Value	Unit	Text
Total Volume	0.034	Fluid Ounce

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 68 – 77 Degrees Fahrenheit