FDA UDI Not in Commercial Distribution 🇺🇸 United States

8250 BALLOON VALVE

DI: 00874750008773 · Model: 8250 · HANS RUDOLPH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
8250 BALLOON VALVE
Primary DI
00874750008773
Version / Model
8250
Catalog Number
112409
Company Name
HANS RUDOLPH, INC.
Labeler DUNS
007131725
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-11-08
Public Version
3
Public Version Date
2023-06-30
Public Version Status
Update
Public Device Record Key
fedc9899-7d04-49ed-949b-b93c5d01a670
Distribution End Date
2023-06-30

Device Description

8250A 3WAY TSHP INFLBAL 22MMOD

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

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYX Tubing, Pressure And Accessories

GMDN Terms

Code Name
37068 Pulmonary function valve

Identifiers

Type ID
Primary 00874750008773