FDA UDI Not in Commercial Distribution 🇺🇸 United States

COMBI *M sensor 82

DI: 05700693095189 · Model: 0605000 · Radiometer Basel AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
COMBI *M sensor 82
Primary DI
05700693095189
Version / Model
0605000
Catalog Number
0605000
Company Name
Radiometer Basel AG
Labeler DUNS
481337657
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-01
Public Version
4
Public Version Date
2022-06-22
Public Version Status
Update
Public Device Record Key
c77f0260-8f32-4539-9ef9-ef122a55db88
Distribution End Date
2019-02-07

Device Description

COMBI *M sensor 82

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
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KLK Monitor, oxygen, cutaneous, for infant not under gas anesthesia
LKD MONITOR, CARBON-DIOXIDE, CUTANEOUS

GMDN Terms

Code Name
37178 Transcutaneous blood gas monitor sensor

Identifiers

Type ID
Primary 05700693095189

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
-10 – 50 Degrees Celsius