FDA UDI In Commercial Distribution 🇺🇸 United States

INTERSURGICAL ECOLITE, PAEDIATRIC, AEROSOL MASK

DI: 05030267104994 · Model: 1198015 · Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
INTERSURGICAL ECOLITE, PAEDIATRIC, AEROSOL MASK
Primary DI
05030267104994
Version / Model
1198015
Company Name
Intersurgical Incorporated
Labeler DUNS
785952607
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-11
Public Version
2
Public Version Date
2022-02-07
Public Version Status
Update
Public Device Record Key
6cafb75f-72ce-48af-b69d-7658173ae9ba

Device Description

INTERSURGICAL ECOLITE, PAEDIATRIC, AEROSOL MASK

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
Yes
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYG Mask, Oxygen

GMDN Terms

Code Name
35142 Aerosol face mask, rebreathing, single-use

Identifiers

Type ID
Package 05030267107193
Primary 05030267104994

Customer Contacts

Phone
3154512900