CarePoint Precision

GUDID 00786227016078

60mL Luer Slip Syringe

ALLISON MEDICAL, INC.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

Primary Device ID	00786227016078
NIH Device Record Key	1e921e21-249f-49b2-89ff-ecd8d8bbc3f0
Commercial Distribution Status	In Commercial Distribution
Brand Name	CarePoint Precision
Version Model Number	01-0060
Company DUNS	825097264
Company Name	ALLISON MEDICAL, INC.
Device Count	25
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter
Total Volume	60 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00786227016016 [Unit of Use]
GS1	00786227016054 [Primary]
GS1	00786227016078 [Package] Contains: 00786227016054 Package: Case [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K124037

FDA Product Code

FMF	Syringe, Piston

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-12-07
Device Publish Date	2023-11-29

On-Brand Devices [CarePoint Precision]

00786227230078	30G x 1/2" Poly Hub Needle
00786227227078	27G x 1/2" Poly Hub Needle
00786227225579	25G x 5/8" Poly Hub Needle
00786227225173	25G x 1-1/2" Poly Hub Needle
00786227225074	25G x 1" Poly Hub Needle
00786227223179	23G x 1-1/2" Poly Hub Needle
00786227223070	23G x 1" Poly Hub Needle
00786227222172	22G x 1-1/2" Poly Hub Needle
00786227222011	22G x 1" Poly Hub Needle
00786227221571	1ml Luer Slip TB with 25G x 5/8" Needle
00786227221175	21G x 1-1/2" Poly Hub Needle
00786227221076	21G x 1" Poly Hub Needle
00786227220079	20G x 1" Poly Hub Needle
00786227218175	18G x 1-1/2" Poly Hub Needle
00786227218076	18G x 1" Poly Hub Needle
00786227053974	3ml Luer Lock Syringe w/ 25G x 1"
00786227053875	3ml Luer Lock Syringe w/ 23g x 1.5”
00786227053776	3ml Luer Lock Syringe w/ 23G x 1"
00786227053677	3ml Luer Lock Syringe w/ 22G x 1.5"
00786227053578	3ml Luer Lock Syringe w/ 22G x 1"
00786227053370	3mL Luer Lock Syringe w/ 21G x 1"
00786227053271	3ml Luer Lock Syringe w/ 20G x 1.5"
00786227053172	3ml Luer Lock Syringe w/ 20G x 1"
00786227053073	3ml Luer Lock Syringe w/ 25G x 1.5"
00786227046570	60mL Catheter Tip Syringe
00786227046075	60mL Luer Lock Syringe
00786227043074	30mL Luer Lock Syringe
00786227042077	20mL Luer Lock Syringe
00786227041070	10mL Luer Lock Syringe
00786227040578	5mL Luer Lock Syringe
00786227040370	3mL Luer Lock Syringe
00786227040172	1mL Luer Lock Syringe
00786227016078	60mL Luer Slip Syringe
00786227010175	1mL Luer Slip Syringe