FDA UDI In Commercial Distribution 🇺🇸 United States

Disposable Mechanical Ventilation Circuit

DI: 04049098061858 · Model: MU04771 · DRAEGER MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20

Basic Information

Brand Name
Disposable Mechanical Ventilation Circuit
Primary DI
04049098061858
Version / Model
MU04771
Company Name
DRAEGER MEDICAL SYSTEMS, INC.
Labeler DUNS
788289952
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2025-12-10
Public Version
1
Public Version Date
2025-12-18
Public Version Status
New
Public Device Record Key
052b6b05-acc8-415c-85a7-b63ee71b3a32

Device Characteristics

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FPL Incubator, Neonatal Transport

GMDN Terms

Code Name
37706 Ventilator breathing circuit, single-use

Identifiers

Type ID
Unit of Use 04049098041829
Primary 04049098061858

Premarket Submissions

Submission Number Supplement Number
K001019 000