FDA UDI In Commercial Distribution 🇺🇸 United States

HeartSpan®

DI: 00884450451663 · Model: 00884450451663 · Merit Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
HeartSpan®
Primary DI
00884450451663
Version / Model
00884450451663
Catalog Number
FND01901
Company Name
Merit Medical
Labeler DUNS
065673912
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-12-08
Public Version
2
Public Version Date
2021-03-30
Public Version Status
Update
Public Device Record Key
012ac79f-59f4-435f-ab40-6b5488e5573b

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DRC Trocar

GMDN Terms

Code Name
47248 Cardiac transseptal needle, single-use

Identifiers

Type ID
Primary 00884450451663