BD PosiFlush SafeScrub

Primary DI
30382903031918
Brand
BD PosiFlush SafeScrub
Company
BECTON, DICKINSON AND COMPANY
Model
303191
Catalog number
303191
Device description
SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB
Published
2022-10-05
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
QTISaline Vascular Access Flush with integrated Alcohol Disinfectant Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213955000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2139550000.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrubBecton, Dickinson and Company2022-07-16QTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382903031918PackageGS130In Commercial Distribution
50382903031912PrimaryGS10
00382903031917Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290303191830382903031918
5038290303191250382903031912
00382903031917003829030319173829030319170382903031917

GMDN Terms#

Term, Definition table
TermDefinition
Vascular access device flush/disinfection toolA manual device intended to be used to flush wash the lumen of an in situ vascular access device (e.g., catheter, needleless intravenous line) and to disinfect the device’s Luer access valve. It consists of a prefilled syringe containing a saline solution, and a disinfection cap or scrubber containing a foam material saturated with disinfectant [e.g., isopropyl alcohol (IPA)]. It may be supplied as a one-piece or modular device. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007263197
Device count
480
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382903031917BD PosiFlush SafeScrubBECTON, DICKINSON AND COMPANYQTI2022-10-05