FDA.reportPublic FDA data

CAINA

Primary DI
46971564464343
Brand
CAINA
Company
Jiangsu Caina Medical Co.,Ltd
Model
1mL
Device description
NRFit Syringe Lock 1 mL
Published
2026-04-14
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
QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact General Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181374000NRFit SyringeJiangsu Caina Medical Co.,Ltd2018-12-14QEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
56971564464340PackageGS110In Commercial Distribution
66971564464347PackageGS1180In Commercial Distribution
46971564464343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5697156446434056971564464340
6697156446434766971564464347
4697156446434346971564464343

GMDN Terms#

Term, Definition table
TermDefinition
Neuraxial syringeA sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications (to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes). At the distal end of the barrel is a male connector, designed according to ISO 80369-6 (often referred to as an NRFit connection), intended specifically for connection to neuraxial devices (e.g., needles, catheters, tubing) with the appropriate NRFit connection. This is a single-use device.

Regulatory Flags#

DUNS number
544543513
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
46971564464336CAINA"21Gx3/4"""2026-04-14
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
06971564465229CAINA23G×1-02CN23102021-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B212576031Female NRFit Tip CapINTERNATIONAL MEDICAL INDUSTRIES INC.QEH2026-01-23
B212576032Female NRFit Tip CapINTERNATIONAL MEDICAL INDUSTRIES INC.QEH2026-01-23
00382904000509BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904000516BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001728BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001735BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001742BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001759BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001827BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
00382904001834BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904000504BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904000511BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001723BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001730BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
30382904001743BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001754BD Syringe NRFit™ SlipBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001822BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21
50382904001839BD Syringe NRFit™ LokBECTON, DICKINSON AND COMPANYQEH2022-03-21