AccessGUDID - DEVICE: 6in HEPA Capsule with Removable Sticker (00848530010690)

GUDID

Device Identifier (DI) Information

Brand Name: 6in HEPA Capsule with Removable Sticker
Version or Model: BFH6S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BFH6S
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530010690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: 6in HEPA Capsule with Removable Sticker (1/pack)

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):	No
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?
34858	Surgical suction system collection container, single-use	A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Fragile

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 800cc

Device Record Status

Public Device Record Key: c267eed9-bcfd-4a7d-bdc1-574c8b52d93c
Public Version Date: November 28, 2022
Public Version Number: 5
DI Record Publish Date: July 31, 2018