DEVICE: Biowy PICC Catheter S Kit (00851739007156)

Device Identifier (DI) Information

Biowy PICC Catheter S Kit
PICC4SK-S
In Commercial Distribution

Biowy Corporation
00851739007156
GS1

1
033858426 *Terms of Use
PICC 4F Single Lumen Catheter S Kit
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Device Characteristics

MR Safe
No
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?
36257 Peripherally-inserted central venous catheter
A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K192246 000
No CLOSE

Sterilization

Yes
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

7f0cd9a9-0867-4e09-a4d8-c28c6aae3101
June 01, 2021
1
May 24, 2021
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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
00851739007194 5 00851739007156 In Commercial Distribution Inner Box
00851739007200 4 00851739007194 In Commercial Distribution Outer Box
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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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