FDA UDI Not in Commercial Distribution 🇺🇸 United States

N/A

DI: 00884908028867 · Model: MC3B · Medical Components, Inc.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
00884908028867
Version / Model
MC3B
Company Name
Medical Components, Inc.
Labeler DUNS
038000253
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-07-16
Public Version
3
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
f40bb4e2-f2ea-4251-a83a-e14e99a31bca
Distribution End Date
2021-01-29

Device Description

15.5F HEMO-FLOW®/15.5F TITAN TUNNELER

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

GMDN Terms

Code Name
46801 Subcutaneous tunneller, single-use

Identifiers

Type ID
Package 50884908028862
Primary 00884908028867

Customer Contacts

Phone
2152564201