DEVICE: Direct IV Solutions - IV Start Kit (00851491007487)
Device Identifier (DI) Information
Direct IV Solutions - IV Start Kit
2533-20G
In Commercial Distribution
2533-20G
Lynn Medical Instrument Co.
2533-20G
In Commercial Distribution
2533-20G
Lynn Medical Instrument Co.
IV Starter Kit - BD 20G Insyte Catheter, ICU Bravo Connector, 5mm Saline Flush, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
33963 | Peripheral intravenous catheterization support kit |
A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OJS | Tourniquet Kit |
LRS | I.V. Start Kit |
OFN | Winged Intravenous Catheterization Kit |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9028a674-c5a0-4467-b801-3025003785bc
May 01, 2020
1
April 23, 2020
May 01, 2020
1
April 23, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20851491007481 | 50 | 00851491007487 | In Commercial Distribution | CS | |
10851491007484 | 100 | 00851491007487 | In Commercial Distribution | CS |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
1-248-560-4500
customerservie@lynnmed.com
customerservie@lynnmed.com