AccessGUDID - DEVICE: Manufacturing Kit CMExpress® Pump (B101100500PXE0)

GUDID

Device Identifier (DI) Information

Brand Name: Manufacturing Kit CMExpress® Pump
Version or Model: 100-500PXE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CME AMERICA LLC

Primary DI Number: B101100500PXE0
Issuing Agency: HIBCC
Commercial Distribution End Date: October 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 002125419 *Terms of Use

Device Description: Pump, battery 3600mAh, tabletop charger, power cord, Operator's Manual

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:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -13 and 122 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0d2018a-0cb5-48a8-9c6d-3f8488ee32bc
Public Version Date: July 04, 2022
Public Version Number: 4
DI Record Publish Date: July 08, 2020