AccessGUDID - DEVICE: AirTechniques (04260635790592)

GUDID

Device Identifier (DI) Information

Brand Name: AirTechniques
Version or Model: NHP12HA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Baldus Sedation GmbH & Co. KG

Primary DI Number: 04260635790592
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343104962 *Terms of Use

Device Description: Double Nasal Hood Single Use, Pediatric, Scent Happy Apple 12 Hoods individually wrapped in a box To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.

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?
46232	Anaesthesia face mask, single-use	A flexible, form-shaped device designed to be placed over a patient's nose and/or mouth to direct anaesthetic gases to the upper airway. It is made of conductive or non-conductive rubber, polyvinyl chloride (PVC), or other sterilizable materials that produce a soft, flexible cover to create an airtight seal against the patient's face. It typically includes a 22 mm connector (adult) or a 15 mm connector (paediatric), and is available in a range of sizes. It may be stabilized with a headstrap. This device is sometimes used in association with a manual resuscitator. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHA	Mask, Scavenging

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: 29040a51-6fe4-4176-beaa-3280355343ec
Public Version Date: January 13, 2023
Public Version Number: 1
DI Record Publish Date: January 05, 2023