MEDADV

Primary DI
00819667020142
Brand
MEDADV
Company
MEDAS INC
Model
M803
Catalog number
M803
Device description
"SYRINGE 3 PARTS LUER LOCK 10 ML WITH NEEDLE 21G X 1 1/2"""
Published
2018-04-11
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
K083686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083686000BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZESAnhui Kangda Medical Products Co., Ltd.2009-07-02FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819667020149PackageGS1100In Commercial Distribution
00819667020142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081966702014910819667020149
00819667020142008196670201428196670201420819667020142

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(786)832-0459customerservice@medasusa.com

Regulatory Flags#

DUNS number
080593067
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819667020746MEDADVM95F61135JM95F61135J2018-04-09
00819667020753MEDADVM95R50721SM95R0721S2018-04-09
00819667020784MEDADVM962P0SM962P0S2018-04-11
00819667020791MEDADVM962P20XLM962P20XL2018-04-11
00819667020807MEDADVM962P20M962P202018-04-11
00819667020814MEDADVM962P20LM962P20L2018-04-11
00819667020647MEDADVM93135150AM93135150A2018-04-11
00819667020654MEDADVM93135260AM93135260A2018-04-09
00819667020166MEDADVM101M1012018-04-12
00819667020982MEDADVM507M5072018-04-11
00819667020258MEDADVM209M2092018-04-10
00819667020265MEDADVM206M2062018-04-11
00819667020272MEDADVM207M2072018-04-10
00819667020289MEDADVM210M2102018-04-09
10819667020064MEDADVM711M7112018-03-01
10819667020071MEDADVM712M7122018-03-01
10819667020088MEDADVM713M7132018-03-01
10819667020095MEDADVM714M7142018-03-01
10819667020101MEDADVM716M7162018-03-01
10819667020118MEDADVM717M7172018-03-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040194307Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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