FDA.reportPublic FDA data

ASSURE® ID Insulin 1cc Safety Syringe

Primary DI
00015482102913
Brand
ASSURE® ID Insulin 1cc Safety Syringe
Company
ARKRAY USA, INC.
Model
210291
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
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
10015482102910PackageGS1100Not in Commercial Distribution
20015482102917PackageGS15Not in Commercial Distribution
00015482102913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548210291010015482102910
2001548210291720015482102917
00015482102913000154821029130154821029130015482102913

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
Length0.5Inch
Needle Gauge29Gauge
Total Volume1Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
008171162
Device count
1
Lot or batch
true
Expiration date on label
true

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00015482510053Assure® Control - Control Solution Level 25100052019-04-01
00015482510077Assure® Control - Control Solution Level 35100072019-04-01
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
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10015482102910ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
10015482102958ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
30015482501779Assure® Platinum Blood Glucose Meter5011772022-06-17
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