AccessGUDID - DEVICE: AIV (M745BC10746)

GUDID

Device Identifier (DI) Information

Brand Name: AIV
Version or Model: BC10746
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: BC10746
Company Name: AMERICAN IV PRODUCTS, INC.

Primary DI Number: M745BC10746
Issuing Agency: HIBCC
Commercial Distribution End Date: September 24, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 181184474 *Terms of Use

Device Description: Patient Pendant Bolus Cables

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
MRZ	Accessories, Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120209	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 -20 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 6 Feet
Outer Diameter: 0.170 Inch

Device Record Status

Public Device Record Key: 07263e0c-b2c0-4084-a7a6-7e0e49e3c6d0
Public Version Date: September 26, 2019
Public Version Number: 4
DI Record Publish Date: September 02, 2016