DEVICE: MediChoice (10885632113949)

Device Identifier (DI) Information

MediChoice
IVS2010
In Commercial Distribution

OWENS & MINOR DISTRIBUTION, INC.
10885632113949
GS1

1
007941230 *Terms of Use
Kit IV Start Tegaderm 2-3/8x2-3/4 Chlorascrub Pad Transpore Tape 1x18 Inch Lbl Dressing Change Without Logo MediChoice
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
LRS I.V. start kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K923361 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Avoid freezing and excessive heat
Handling Environment Temperature: between 0 and 40 Degrees Celsius
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Clinically Relevant Size

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

34c05997-1171-49d3-a646-991e74683538
October 16, 2023
3
October 12, 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
50885632113947 100 10885632113949 In Commercial Distribution
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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
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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