FDA UDI Not in Commercial Distribution 🇺🇸 United States

AMSafe ® I.V Administration Set 100''

DI: 10704411016243 · 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 100''
Primary DI
10704411016243
Version / Model
1
Catalog Number
FP100F12Y1
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-18
Public Version
1
Public Version Date
2023-08-28
Public Version Status
New
Public Device Record Key
7dcdda97-4b9e-4ae6-b334-83965d97180f
Distribution End Date
2023-08-18

Device Description

For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter, (1) Sure-Lok Needle-Free valve, Rotating Male Luer Lock with Retractable Collar, Approx. Priming Volume: 22mL

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
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
58977 Basic intravenous administration set, noninvasive

Identifiers

Type ID
Package 40704411016244
Primary 10704411016243