DEVICE: Syringe LL, W/BioCare Safety Needle (00858835007745)
Device Identifier (DI) Information
Syringe LL, W/BioCare Safety Needle
GE1061S
In Commercial Distribution
GE1061S
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE1061S
In Commercial Distribution
GE1061S
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Disposable 5cc Syringe LL, W/BioGuard Safety Needle 21G 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 |
59230 | Hypodermic needle, single-use |
A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FMI | Needle, Hypodermic, Single Lumen |
FMF | Syringe, Piston |
MEG | Syringe, Antistick |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112057 | 000 |
K190183 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Disposable 5cc Syringe LL, W/BioCare Safety Needle 21G x 1 1/2" |
Device Record Status
c69515b6-5b6f-44c4-bc52-af903b87f42a
October 21, 2024
6
October 09, 2019
October 21, 2024
6
October 09, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20858835007749 | 12 | 10858835007742 | In Commercial Distribution | Case | |
10858835007742 | 100 | 00858835007745 | In Commercial Distribution | Inner Box |
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
[?]
786-473-9436
mborges@biotronixhealthcare.com
mborges@biotronixhealthcare.com