AccessGUDID - DEVICE: Plum Duo Infusion System (M335400021)

GUDID

Device Identifier (DI) Information

Brand Name: Plum Duo Infusion System
Version or Model: 1.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400020401
Company Name: ICU MEDICAL, INC.

Primary DI Number: M335400021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118380146 *Terms of Use

Device Description: Plum Duo Dual Channel Infusion System

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?
17634	Bedside infusion pump, multichannel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the simultaneous, accurate, and consistent administration of multiple drugs/solutions (multichannel) from a standard infusion bag or bottle, via intravenous, subcutaneous, arterial, epidural, and intracavital routes, using a dedicated infusion set. It is not dedicated to a specific treatment type and is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223607	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: 93a24d2a-1b5b-43b5-88ee-ca3215827157
Public Version Date: November 15, 2023
Public Version Number: 2
DI Record Publish Date: October 13, 2023

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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(866)829-9025
Email: customerservice@icumed.com

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