FDA.reportPublic FDA data

CarePoint Precision

Primary DI
00786227223155
Brand
CarePoint Precision
Company
ALLISON MEDICAL, INC.
Model
202-2315
Device description
"23G x 1-1/2"" Poly Hub Needle"
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00786227223179PackageGS140In Commercial Distribution
00786227223155PrimaryGS10
00786227223117Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00786227223179007862272231797862272231790786227223179
00786227223155007862272231557862272231550786227223155
00786227223117007862272231177862272231170786227223117

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch
Needle Gauge23Gauge

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
00786227053257CarePoint Precision505-31052023-11-29
00786227053356CarePoint Precision505-31112023-11-29

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