FDA UDI In Commercial Distribution 🇺🇸 United States

CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M

DI: 05030267104987 · Model: 1454015 · Intersurgical Incorporated
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M
Primary DI
05030267104987
Version / Model
1454015
Company Name
Intersurgical Incorporated
Labeler DUNS
785952607
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-07-12
Public Version
1
Public Version Date
2022-07-20
Public Version Status
New
Public Device Record Key
03ec2e27-fd2e-44a1-bb46-571a0824ff8e

Device Description

CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M

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
No
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
CAF Nebulizer (Direct Patient Interface)

GMDN Terms

Code Name
31309 Nebulizing system delivery set, single-use

Identifiers

Type ID
Primary 05030267104987

Customer Contacts

Phone
3154512900

Premarket Submissions

Submission Number Supplement Number
K911422 000