FDA.report

Merit Medical®

Primary DI
10884450136635
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450136638
Catalog number
K01-07538
Published
2018-09-17
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

Related Records

Product Codes

CodeName
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884450136635PackageGS125In Commercial Distribution
20884450136632PackageGS14In Commercial Distribution
00884450136638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445013663510884450136635
2088445013663220884450136632
00884450136638008844501366388844501366380884450136638

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
184763290
Device count
1
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

Other Devices From This Company

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10884450423629Merit Medical®Initial ReleaseK09-13891B2026-03-24
10884450425333Merit Medical®Initial ReleaseK10-01481A2026-03-24
20884450430815Merit Medical®Initial ReleaseK09-05342B2026-03-24
10884450430863Merit Medical®Initial ReleaseK09-10929A2026-03-24
00884450458426DuraMax®BH7871030282252026-03-24
10884450529581SplashWire™Initial ReleaseMSWSTFS352202026-03-24
10884450845223Merit Medical®D3339-312026-03-24
10884450027339Merit Medical®Initial ReleaseK04-01029A2026-03-20
10884450112721Merit Medical®Initial ReleaseK09-10994G2026-03-21
20884450164918Merit Medical®Initial ReleaseK09-12174B2026-03-21
10884450428532Merit Medical®Initial ReleaseK09-09762A2026-03-21
10884450430788Merit Medical®Initial ReleaseK10-05773A2026-03-21
10884450430856Merit Medical®Initial ReleaseK09-04213A2026-03-21
10884450440602Merit Medical®Initial ReleaseK09-11433M2026-03-21
20884450441514Merit Medical®Initial ReleaseK09-14148B2026-03-21
20884450441552Merit Medical®Initial ReleaseK12-12053B2026-03-21
10884450441784SteadySheath®BLR-TSS-13.02026-03-21

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18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
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18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
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00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13