FDA UDI In Commercial Distribution 🇺🇸 United States

Neonatal 35in Heated Wire System W/Water Trap

DI: 05055788745341 · Model: 038-03-165U · FLEXICARE MEDICAL LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Neonatal 35in Heated Wire System W/Water Trap
Primary DI
05055788745341
Version / Model
038-03-165U
Company Name
FLEXICARE MEDICAL LIMITED
Labeler DUNS
504406273
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-11
Public Version
2
Public Version Date
2022-10-24
Public Version Status
Update
Public Device Record Key
70dd3b44-677d-44e3-835d-fdb914687c9d

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
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
Yes
Sterilization Prior Use
No

Product Codes

Code Name
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

GMDN Terms

Code Name
37706 Ventilator breathing circuit, single-use

Identifiers

Type ID
Primary 05055788745341