AccessGUDID - DEVICE: Airtraq (08436031033922)

GUDID

Device Identifier (DI) Information

Brand Name: Airtraq
Version or Model: A-390-KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRODOL MEDITEC, SA

Primary DI Number: 08436031033922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 541001090 *Terms of Use

Device Description: Airtraq A-390 WiFi Camera KIT

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:	No
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?
64798	Video intubation laryngoscope imaging system	An assembly of video-imaging devices intended to be user-installed in a video intubation laryngoscope blade/handle shell (not included) to make functional a video intubation laryngoscope, enabling video imaging of the trachea during insertion of an endotracheal (ET) tube. It includes an electronic camera with integrated light, designed to be installed at the distal end of the blade, with dedicated software installed in a smartphone designed to be mounted on the handle; the smartphone provides power to, and receives image data from, the integrated camera. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

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
No Device Sizes

Device Record Status

Public Device Record Key: f815cebe-f453-4e9d-b822-d136de301c89
Public Version Date: August 09, 2023
Public Version Number: 1
DI Record Publish Date: August 01, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
78436031033921	5	08436031033922		In Commercial Distribution	Box

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES