AccessGUDID - DEVICE: Buffalo Filter (00851136002334)

GUDID

Device Identifier (DI) Information

Brand Name: Buffalo Filter
Version or Model: PSFTS05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PSFTS05
Company Name: Buffalo Filter

Primary DI Number: 00851136002334
Issuing Agency: GS1
Commercial Distribution End Date: April 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 787855907 *Terms of Use

Device Description: Speculum Tubing

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":	Yes
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?
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAZ	Tubing, Noninvasive

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 0.825 Inch
Length: 6 Feet
Length: 2 Feet
Lumen/Inner Diameter: 0.25 Inch

Device Record Status

Public Device Record Key: 0af05947-9d31-47e4-96b6-89eb44e1e46f
Public Version Date: May 03, 2024
Public Version Number: 5
DI Record Publish Date: January 06, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851136002331	5	00851136002334	2022-04-21	Not in Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 716-835-7000
Email: bf.smoke.info@filtrationgroup.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES