FDA.reportPublic FDA data

CarePoint Precision

Primary DI
00786227053257
Brand
CarePoint Precision
Company
ALLISON MEDICAL, INC.
Model
505-3105
Device description
"3ml Luer Lock Syringe w/ 20G x 1.5"""
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124037000JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLEJung Rim Medical Industrial Co., Ltd.2013-09-12FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00786227053271PackageGS124In Commercial Distribution
00786227053257PrimaryGS10
00786227053219Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786227053271007862270532717862270532710786227053271
00786227053257007862270532577862270532570786227053257
00786227053219007862270532197862270532190786227053219

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Needle Gauge20Gauge
Total Volume3Milliliter

Regulatory Flags#

DUNS number
825097264
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00087701190605Good Neighbor Pharmacy102935792025-01-16
00087701190612Good Neighbor Pharmacy102940952025-01-16
00087701190629Good Neighbor Pharmacy102935792025-01-16
00087701190636Good Neighbor Pharmacy102937092025-01-16
00087701190643Good Neighbor Pharmacy102938812025-01-16
00087701190650Good Neighbor Pharmacy102938622025-01-16
00786227010151CarePoint Precision01-00012023-11-29
00786227016054CarePoint Precision01-00602023-11-29
00786227040158CarePoint Precision04-00012023-11-29
00786227040356CarePoint Precision04-00032023-11-29
00786227040554CarePoint Precision04-00052023-11-29
00786227041056CarePoint Precision04-00102023-11-29
00786227042053CarePoint Precision04-00202023-11-29
00786227043050CarePoint Precision04-00302023-11-29
00786227046051CarePoint Precision04-00602023-11-29
00786227046556CarePoint Precision04-00652023-11-29
00786227053059CarePoint Precision505-31552023-11-29
00786227053158CarePoint Precision505-31012023-11-29
00786227053356CarePoint Precision505-31112023-11-29
00786227053554CarePoint Precision505-31212023-11-29

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