FDA.report

droplet insulin syringe

Primary DI
25907996095647
Brand
droplet insulin syringe
Company
HTL STREFA S A
Model
1ml, 30G x 12.5 mm
Catalog number
6007
Device description
droplet insulin syringe with fixed needle is a sterile single use syringe for the injection of U-100 insulin only.
Published
2018-09-17
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
05907996095797PackageGS110In Commercial Distribution
25907996095647PackageGS15In Commercial Distribution
05907996095643PrimaryGS10
85907996095649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05907996095797059079960957975907996095797
2590799609564725907996095647
05907996095643059079960956435907996095643
8590799609564985907996095649

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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