DEVICE: Nipro Syringe (00383790007238)
Device Identifier (DI) Information
Nipro Syringe
JD+03L2338-NIJ
In Commercial Distribution
NIPRO MEDICAL CORPORATION
JD+03L2338-NIJ
In Commercial Distribution
NIPRO MEDICAL CORPORATION
3mL Luer Lock with attached needle 23G x 1-1/2"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47017 | General-purpose syringe, single-use |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMF | Syringe, Piston |
FMI | Needle, Hypodermic, Single Lumen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191359 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 3 Milliliter |
Needle Gauge: 23 Gauge |
Length: 1.5 Inch |
Device Record Status
8b5cb62c-6be4-4f6d-bc32-b678e2810199
April 26, 2021
1
April 16, 2021
April 26, 2021
1
April 16, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10383790007235 | 100 | 00383790007238 | In Commercial Distribution | BOX | |
40383790007236 | 10 | 10383790007235 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (908) 393-7030
info@nipromed.com
info@nipromed.com