AccessGUDID - DEVICE: Lifecare PCA (M3352070904871)

GUDID

Device Identifier (DI) Information

Brand Name: Lifecare PCA
Version or Model: 20709
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20709
Company Name: HOSPIRA, INC.

Primary DI Number: M3352070904871
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141588017 *Terms of Use

Device Description: PCA with MedNet

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?
35932	Patient-controlled analgesia infusion pump	A battery-powered infusion device designed to deliver intermittent bolus doses of opioid medications [e.g., Fentanyl, Demerol (meperidine), Morphine, or Hydromorphone] upon patient demand (i.e., when activated by the patient when he/she requires pain relief), or in a slow, continuous mode for regional anaesthesia. A patient-controlled analgesia (PCA) infusion pump is used to infuse drugs into an operative site, or subcutaneously for postoperative pain management. It is used for hospital/home-use and can be worn by the patient for ambulation. It will incorporate safety mechanisms to prevent the patient overdosing; some types will employ computerized ambulatory drug delivery (CADD) software.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
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
Special Storage Condition, Specify: Low Value is negative 20 degrees Celsius. High Value is 60 degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 15.1 Inch
Length: 13.143 Inch
Depth: 11.1 Inch

Device Record Status

Public Device Record Key: 01f13a0d-7157-4805-bc45-c65619bc0f41
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 04, 2017