FDA UDI In Commercial Distribution 🇺🇸 United States

Stryker AVA/iVAS® Inflator

DI: 00856877002285 · Model: QL1430 · ATRION MEDICAL PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Stryker AVA/iVAS® Inflator
Primary DI
00856877002285
Version / Model
QL1430
Catalog Number
1031-115-400
Company Name
ATRION MEDICAL PRODUCTS, INC.
Labeler DUNS
047571476
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-10-04
Public Version
6
Public Version Date
2020-11-11
Public Version Status
Update
Public Device Record Key
3b707bfd-5f9f-4bb2-82ac-bfd8ae3849ef

Device Description

Inflation Device Atrion Part Number 96493: 14mL, 400psi

Device Characteristics

Single Use
Yes
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
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

Product Codes

Code Name
KOE Dilator, Urethral
MAV Syringe, Balloon Inflation

GMDN Terms

Code Name
17541 Catheter/overtube balloon inflator, single-use

Identifiers

Type ID
Primary 00856877002285

Customer Contacts