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.
00851491007487
GS1

1
058810771 *Terms of Use
IV Starter Kit - BD 20G Insyte Catheter, ICU Bravo Connector, 5mm Saline Flush, IV Derm Transparent Silicone, Tourniquet, Gauze, Alcohol Prep Pad, & Under Pad
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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.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
OJS Tourniquet Kit
LRS I.V. Start Kit
OFN Winged Intravenous Catheterization Kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9028a674-c5a0-4467-b801-3025003785bc
May 01, 2020
1
April 23, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1-248-560-4500
customerservie@lynnmed.com
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