FDA.reportPublic FDA data

CAINA

Primary DI
16971564465165
Brand
CAINA
Company
Jiangsu Caina Medical Co.,Ltd
Model
1ML LL-01
Catalog number
SN01001
Device description
1 ml luer lock disposable syringe without needle.The syringes are intended to inject fluids into or withdraw fluids from the body.
Published
2021-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K192551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192551000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971564465165PackageGS1100In Commercial Distribution
26971564465162PackageGS18In Commercial Distribution
06971564465168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697156446516516971564465165
2697156446516226971564465162
06971564465168069715644651686971564465168

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA 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 needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It 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
Total Volume1Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544543513
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
46971564464336CAINA"21Gx3/4"""2026-04-14
46971564464343CAINA1mL2026-04-14
06971564465021CAINA25501CA2552020-09-20
06971564465038CAINA25701CA2572020-09-20
06971564465045CAINA323501CA32352020-09-20
06971564465052CAINA325501CA32552020-09-20
06971564465069CAINA125501CA12552020-09-20
06971564465076CAINA123501CA12352020-09-20
06971564465083CAINA320501CA32052020-09-20
06971564465090CAINA322701CA32272020-09-20
06971564465106CAINA25G*5/8-01CA2532020-11-10
06971564465113CAINA1ml LL 30G*1/2-01CA13022020-11-10
06971564465120CAINA3ml LL 21G*1-01CA32152020-11-10
06971564465137CAINA3ml LL 22G*1-01CA32252020-11-10
06971564465144CAINA3ml LL 25G*5/8-01CA32532020-11-10
06971564465151CAINA325502CN32552020-12-01
06971564465175CAINA3ml LL 23G*1-02CN323102021-01-15
06971564465182CAINA3ml LL 23G*1.5-02CN323152021-01-15
06971564465199CAINA3ml LL 25G*1.5-02CN325152021-01-15
06971564465205CAINA1ml LL 23G*1-02CN123102021-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253005059MonojectCardinal Health 200, LLCFMI2026-09-24
10809160538913HalyardMEDICAL ACTION INDUSTRIES INC.FMI2026-09-24
16972857299252REDOX SMART PAN Pen NeedleSandstone Medical (Suzhou) Inc.FMI2026-09-24
MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
00850091070013CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070235CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070242CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070259CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070266CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070273CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070280CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070297CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070303CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070310CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070327CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070334CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070341CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070365CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMI2026-09-04
00850068519361SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519378SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00850068519385SAM MedicalZien Medical Technologies, LLCFMI2026-09-03
00814965020481Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020504Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020528Precision PointGold Coast Medical Supply, LPFMI2026-08-26
00814965020542Precision PointGold Coast Medical Supply, LPFMI2026-08-26