FDA.report

droplet insulin syringes

Primary DI
25907996095593
Brand
droplet insulin syringes
Company
HTL STREFA S A
Model
0.5ml, 31 x 6mm
Catalog number
6002
Device description
droplet insulin syringes with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMFSyringe, Piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05907996095742PackageGS110In Commercial Distribution
25907996095593PackageGS15In Commercial Distribution
05907996095599PrimaryGS10
85907996095588Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05907996095742059079960957425907996095742
2590799609559325907996095593
05907996095599059079960955995907996095599
8590799609558885907996095588

GMDN Terms

TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+17705280410info@htl-strefa.com

Regulatory Flags

DUNS number
422528088
Device count
10
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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