AccessGUDID - DEVICE: ICU Medical MedNet (10887709101811)

GUDID

Device Identifier (DI) Information

Brand Name: ICU Medical MedNet
Version or Model: 6.32.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 160379203
Company Name: ICU MEDICAL, INC.

Primary DI Number: 10887709101811
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: Mednet Software

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHC	Infusion safety management software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141102	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b82d644c-e98e-4568-821c-d3e9927ef955
Public Version Date: January 22, 2020
Public Version Number: 2
DI Record Publish Date: October 09, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)241-4002
Email: TSC.Support@icumed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES