DEVICE: ICU Medical (00887709042537)

Device Identifier (DI) Information

ICU Medical
42328-66
In Commercial Distribution
42328-66
ICU MEDICAL, INC.
00887709042537
GS1

1
118380146 *Terms of Use
24" Safeset™Reservoir w/Needleless Valve
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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?
45760 In-line arterial blood sampling set
A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KRA Catheter, continuous flush
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K932188 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

cd8d6e3a-fa00-4ecc-8419-dc9ede9cb99a
September 06, 2021
1
August 29, 2021
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10887709042534 20 00887709042537 In Commercial Distribution CS
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)829-9025
customerservice@icumed.com
CLOSE