AccessGUDID - DEVICE: Refurbished BodyGuard® 121 Twins Pump (B101100908PTSR0)

GUDID

Device Identifier (DI) Information

Brand Name: Refurbished BodyGuard® 121 Twins Pump
Version or Model: 100-908PTSR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CME AMERICA LLC

Primary DI Number: B101100908PTSR0
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: Refurbished Pump, Pole Mount 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?
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
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
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: c6ca91d7-d925-4c04-8625-833ebb2a33d8
Public Version Date: September 23, 2022
Public Version Number: 6
DI Record Publish Date: September 15, 2016