AccessGUDID - DEVICE: AIRSEAL (10851885004013)

GUDID

Device Identifier (DI) Information

Brand Name: AIRSEAL
Version or Model: SEM-EVAC
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SEM-EVAC
Company Name: Conmed Corporation

Primary DI Number: 10851885004013
Issuing Agency: GS1
Commercial Distribution End Date: March 27, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: AIRSEAL BIFURCATED SMOKE EVAC FILTERED SUBE SET

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?
60738	Endoscopic insufflation tubing set, single-use	A collection of flexible tubing intended to channel medical gas [e.g., carbon dioxide (CO2), medical air] from its source into a body cavity for insufflation during endoscopy (e.g., gastrointestinal endoscopy, laparoscopy, arthroscopy). It includes synthetic polymer tubing and associated connectors; it may in addition be intended for endoscopic lens drying, and may include additional tubing for delivery of a sterile irrigation solution for endoscopic irrigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIF	INSUFFLATOR, LAPAROSCOPIC

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6700b7a7-68f5-44c9-b68e-9d2c14a18381
Public Version Date: March 28, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016