AccessGUDID - DEVICE: Pentair (B462DBF32K04FD5)

GUDID

Device Identifier (DI) Information

Brand Name: Pentair
Version or Model: DBF32K04FD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DBF32K04
Company Name: PENTAIR FILTRATION SOLUTIONS, LLC

Primary DI Number: B462DBF32K04FD5
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 057656759 *Terms of Use

Device Description: No description.

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:	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?
11711	Non-respiratory device ambient air filter	A filter designed to be installed in a non-respiratory device to clean the ambient air that passes through it to facilitate device operation/management. It is composed of tightly woven materials which remove particulates/impurities and, depending on how the device is installed, reduce the concentration of impurities to or from the air. It is typically used in devices that draw in ambient air for use as part of their function (e.g., to cool electrical motors, liquidize air as in a flotation therapy bed, wash/disinfect surgical instruments), or devices that, having used the air as a drive gas, exhaust it into a room via the filter. After installation, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAH	Filter, Bacterial, Breathing-Circuit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061426	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 50 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 890a29ac-d462-446e-b9fc-baf18134db0b
Public Version Date: February 06, 2020
Public Version Number: 4
DI Record Publish Date: December 31, 2017