FDA UDI In Commercial Distribution 🇺🇸 United States

AMSafe® I.V. Administration Set

DI: 10704411005230 · Model: 1 · AMSINO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
AMSafe® I.V. Administration Set
Primary DI
10704411005230
Version / Model
1
Catalog Number
MRS102
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-23
Public Version
4
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
a3dd3fd6-0825-4375-8043-e62eb8d49245

Device Description

AMSafe® I.V. Administration Set 100" (254 cm) 10 Drop Vented/Non-Vented Gravity Admin Set with Flow Controller, MicroClave® Clear, Slide Clamp, Rotating Male Luer Lock. Approx. Priming Volume: 20mL

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
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
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
58977 Basic intravenous administration set, noninvasive

Identifiers

Type ID
Package 40704411005231
Primary 10704411005230