DEVICE: Biotronix HealthCare Syringes (00858835007202)
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If so, send a picture of the label to
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Device Identifier (DI) Information
Biotronix HealthCare Syringes
GE12012
In Commercial Distribution
GE12012
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12012
In Commercial Distribution
GE12012
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each
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? |
|---|---|---|---|---|
| 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 |
| 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 [?] |
|---|---|
| K060211 | 000 |
| K222124 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each |
Device Record Status
ef262936-60bc-46e5-a641-0bf31255237f
November 04, 2024
7
October 10, 2019
November 04, 2024
7
October 10, 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 |
|---|---|---|---|---|---|
| 20858835007206 | 10 | 10858835007209 | In Commercial Distribution | Case | |
| 10858835007209 | 100 | 00858835007202 | 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