FDA UDI
In Commercial Distribution
🇺🇸 United States
CAINA
DI: 46971564464343
·
Model: 1mL
·
Jiangsu Caina Medical Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- CAINA
- Primary DI
- 46971564464343
- Version / Model
- 1mL
- Company Name
- Jiangsu Caina Medical Co.,Ltd
- Labeler DUNS
- 544543513
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-14
- Public Version
- 1
- Public Version Date
- 2026-04-22
- Public Version Status
- New
- Public Device Record Key
- 17db6d3b-7776-4d67-98f6-f33b1a6065b4
Device Description
NRFit Syringe Lock 1 mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QEH | Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63603 | Neuraxial syringe | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 56971564464340 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 46971564464343 | GS1 | ||||
| Package | 66971564464347 | GS1 | 180 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181374 | 000 |