FDA UDI In Commercial Distribution 🇺🇸 United States

AirTechniques

DI: 04260635790158 · Model: NHAP101 · Baldus Sedation GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AirTechniques
Primary DI
04260635790158
Version / Model
NHAP101
Company Name
Baldus Sedation GmbH & Co. KG
Labeler DUNS
343104962
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-12-02
Public Version
1
Public Version Date
2022-12-12
Public Version Status
New
Public Device Record Key
5730d156-3509-442f-8917-61f40f2869f6

Device Description

To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxyg Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
KHA Mask, Scavenging

GMDN Terms

Code Name
35176 Anaesthesia face mask, reusable

Identifiers

Type ID
Primary 04260635790158