FDA UDI Not in Commercial Distribution 🇺🇸 United States

MicroMax Blender

DI: 00853061006197 · Model: R203P13-007 · MAXTEC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
MicroMax Blender
Primary DI
00853061006197
Version / Model
R203P13-007
Company Name
MAXTEC, LLC
Labeler DUNS
169911828
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-14
Public Version
2
Public Version Date
2019-05-07
Public Version Status
Update
Public Device Record Key
5e91b7c3-f405-413d-bf5e-9602a03b1222
Distribution End Date
2019-05-06

Device Description

Low Flow DISS Dextro Labeled

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
No
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BZR Mixer, Breathing Gases, Anesthesia Inhalation

GMDN Terms

Code Name
44225 Oxygen/air breathing gas mixer, hospital

Identifiers

Type ID
Primary 00853061006197

Premarket Submissions

Submission Number Supplement Number
K053232 000