AccessGUDID - DEVICE: Airtraq (08436031030310)

GUDID

Device Identifier (DI) Information

Brand Name: Airtraq
Version or Model: A-031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRODOL MEDITEC, SA

Primary DI Number: 08436031030310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 541001090 *Terms of Use

Device Description: Airtraq SP Pediatric

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
64884	Channelled video intubation laryngoscope	A hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube channel guide without use of a stylet for positioning. It typically consists of a body with an ET tube channel, an anatomically-shaped blade, and integrated electronic illumination and a video camera at the distal end; images are transmitted to an off-the-shelf device (e.g., tablet, smartphone, computer). This is a single-use device.	Obsolete	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: de5ccdf8-811f-45e9-ae11-352572ce2c2b
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
48436031030318	2	08436031030310		In Commercial Distribution	Box
38436031030311	30	48436031030318		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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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