AccessGUDID - DEVICE: ACTion Fuser Pump, 650ml, 5-15 ml/hr140mm caut-to-size catheter (05707480120932)

GUDID

Device Identifier (DI) Information

Brand Name: ACTion Fuser Pump, 650ml, 5-15 ml/hr140mm caut-to-size catheter
Version or Model: 418104650
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 418104650
Company Name: Ambu A/S

Primary DI Number: 05707480120932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305682023 *Terms of Use

Device Description: ACTion Fuser 650 ml, 5-15 ml/hr, 140 mm Cut-to-size

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:	Yes
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?
47190	Elastomeric infusion pump kit	A collection of sterile devices designed to enable a healthcare provider or patient to perform infusion therapy using an elastomeric infusion pump. The kit typically consists of the infusion pump and other devices such as a catheter, tunneller, needle, sheath, syringe, dressings, adhesive strips, and a filling device for the infusion pump. This device is typically used for the infusion of fluids, antibiotics, chemotherapeutic agents, or pain management medications in the healthcare facility or the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEB	PUMP, INFUSION, ELASTOMERIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061409	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 -15 and 40 Degrees Celsius
Handling Environment Temperature: between -50 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 650 Milliliter
Length: 140 Millimeter

Device Record Status

Public Device Record Key: b168b3c9-44aa-4953-b85b-ad41bcba4641
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016