AccessGUDID - DEVICE: Refurbished CMExpress® Pump Pole Mount Charger (B101150386XR0)

GUDID

Device Identifier (DI) Information

Brand Name: Refurbished CMExpress® Pump Pole Mount Charger
Version or Model: 150-386XR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CME AMERICA LLC

Primary DI Number: B101150386XR0
Issuing Agency: HIBCC
Commercial Distribution End Date: March 20, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 002125419 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
13215	Bedside infusion pump, single-channel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It 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) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion
MEA	Pump, Infusion, Pca

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042696	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: 3c0784c6-fec3-4673-b2bb-b55b63506e33
Public Version Date: July 04, 2022
Public Version Number: 6
DI Record Publish Date: September 16, 2016