FDA UDI In Commercial Distribution 🇺🇸 United States

Luna® G3 BPAP 25A

DI: 06948538365632 · Model: LG3700 · BMC Medical Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Luna® G3 BPAP 25A
Primary DI
06948538365632
Version / Model
LG3700
Company Name
BMC Medical Co., Ltd.
Labeler DUNS
526010310
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-08-26
Public Version
2
Public Version Date
2022-11-09
Public Version Status
Update
Public Device Record Key
02b0c7ac-fec5-4a1f-a26a-345c25023291

Device Description

Luna® G3 BPAP 25A

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BZD Ventilator, Non-Continuous (Respirator)

GMDN Terms

Code Name
60712 Home BPAP unit

Identifiers

Type ID
Primary 06948538365632