BD Texium

Primary DI
10885403221675
Brand
BD Texium
Company
BD Switzerland Sàrl
Model
MY8010
Catalog number
MY8010
Device description
10 mL Needle-Free Syringe
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231888000BD Texium™ Needle-Free SyringeCare Fusion2023-09-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403221673PackageGS1100In Commercial Distribution
10885403221675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540322167350885403221673
1088540322167510885403221675

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Storage temperature
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)823-5433customer_support@bd.com

Regulatory Flags#

DUNS number
482631558
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403237898Tru-SecureTS1000TS10002016-10-17
00382903949106Connecta, Luer-Lok3949103949102023-09-21
00382905156298BD PhaSeal Optima5156295156292026-01-09
30382905156299BD PhaSeal Optima5156295156292026-01-09
00382905156281BD PhaSeal Optima5156285156282025-12-19
30382905156282BD PhaSeal Optima5156285156282025-12-19
10885403235610AlarisC25012C250122016-09-22
07613203010931Alaris, SmartSite42290E42290E2016-10-17
07613203010962Alaris, SmartSite42273E42273E2016-09-22
10885403222610AlarisMS3500-15MS3500-152016-09-22
10885403234859Alaris, SmartSite20027E20027E2016-09-22
10885403235306Alaris, SmartSite41177E41177E2016-09-22
10885403274220Alaris, SmartSite41176E41176E2016-09-22
10885403230110Alaris10016073100160732016-09-22
07613203010917Alaris, SmartSite42293E42293E2016-09-22
10885403236532BD MaxPlusMP2000MP20002016-09-22
10885403236778BD MaxPlusMP9004MP90042016-09-22
10885403236990BD MaxPlusMP9218-CMP9218-C2016-09-22
10885403302060Alaris, SmartSiteMPC-02MPC-022016-09-22
00382905150012BD PhaSeal5150015150012016-09-19

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Primary DI, Brand, Company table
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