DEVICE: ARROW (10801902011937)

Device Identifier (DI) Information

ARROW
IPN046436
In Commercial Distribution
MH-05001
TELEFLEX INCORPORATED
10801902011937
GS1

1
002348191 *Terms of Use
00801902011930
TheraCath(R) Epidural Catheterization Kit
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Device Characteristics

MR Unsafe
No
Yes
Yes
Yes
No
Yes
Yes
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?
61911 Epidural anaesthesia set, medicated
A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CAZ Anesthesia conduction kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K801912 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Length: 0 Centimeter
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Device Record Status

9fa55b2c-d37d-4e35-ac5c-d507f34cfe20
May 27, 2022
7
November 07, 2018
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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
20801902011934 10 10801902011937 2022-05-23 Not in Commercial Distribution 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
Yes
No CLOSE

Customer Contact

[?]
+1(919)544-8000
CS@TELEFLEX.COM
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