FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00850022357213 · Model: XE-102D · Medi/Nuclear Corporation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
00850022357213
Version / Model
XE-102D
Company Name
Medi/Nuclear Corporation, Inc.
Labeler DUNS
079628327
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-11-09
Public Version
1
Public Version Date
2020-11-17
Public Version Status
New
Public Device Record Key
c899906f-cbb7-42ff-bc8a-2e26789f0f65

Device Description

Mouthport, Replacement for (HRV) for Xenon/Master Patient Delivery System.

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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
CBP Valve, Non-Rebreathing

GMDN Terms

Code Name
40907 Xenon administration system, diagnostic x-ray/CT

Identifiers

Type ID
Primary 00850022357213

Customer Contacts

Phone
800-321-5981

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
store at room temperature