FDA.reportPublic FDA data

ASSURE® ID Insulin 0.5cc Safety Syringe

Primary DI
00015482102951
Brand
ASSURE® ID Insulin 0.5cc Safety Syringe
Company
Arkray USA, Inc.
Model
210295
Device description
Sterile Safety Syringe
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103011000ULTICARE SAFETY INSULIN SYRINGEUlti-Med Intl., Inc.2011-02-02MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482102958PackageGS1100Not in Commercial Distribution
20015482102955PackageGS15Not in Commercial Distribution
00015482102951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548210295810015482102958
2001548210295520015482102955
00015482102951000154821029510154821029510015482102951

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringe/needleA sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0
Total Volume0

Contacts#

Phone, Email table
PhoneEmail
+1(800)566-8558xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015482000011ARK Care®Version 2.5.3.2016-09-23
00015482100025Assure® Slide Pill Swallowing Aid forte10000022018-12-28
00015482100032Assure® Slide Pill Swallowing Aid zero10000032018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23
00015482238322TechLITE PEN NEEDLES2381322016-09-23

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