FDA UDI In Commercial Distribution 🇺🇸 United States

AMSure® Suction Catheter Tray

DI: 10704411008682 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSure® Suction Catheter Tray
Primary DI
10704411008682
Version / Model
1
Catalog Number
AS391
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-06-12
Public Version
1
Public Version Date
2018-07-13
Public Version Status
New
Public Device Record Key
cd450c91-a438-4e4c-84b9-e48ec6013007

Device Description

AMSure® Suction Catheter Tray SIZE:6Fr. CONTENTS: 1 ea Catheter 1 pair of Vinyl Gloves 1 bottle Sterile 0.9% Saline Solution, 100mL

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
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

Product Codes

Code Name
BSY Catheters, Suction, Tracheobronchial

GMDN Terms

Code Name
13846 Secretion suction kit

Identifiers

Type ID
Package 40704411008683
Primary 10704411008682