FDA.report

MEDLINE INDUSTRIES, INC.

Primary DI
20193489005568
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
SYRS201292
Catalog number
SYRS201292
Device description
DBD-SYR W/NDLE,INSLN,SAFETY,29GX0.5",1ML
Published
2020-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MEGSYRINGE, ANTISTICK

Product Code Classifications

CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489005568PackageGS1100In Commercial Distribution
10888277327443PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348900556820193489005568
1088827732744310888277327443

GMDN Terms

TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume1Milliliter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
true
Sterilization required before use
false

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