FDA UDI In Commercial Distribution 🇺🇸 United States

SunMark

DI: 10612479214818 · Model: 115-93651 · MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
SunMark
Primary DI
10612479214818
Version / Model
115-93651
Company Name
MCKESSON MEDICAL-SURGICAL INC.
Labeler DUNS
023904428
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-12-09
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
512e2ac3-c6a3-4d00-8a3e-a72090af13cd

Device Description

Oximeter

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DQA Oximeter

GMDN Terms

Code Name
17148 Pulse oximeter, line-powered

Identifiers

Type ID
Primary 10612479214818