FDA UDI In Commercial Distribution 🇺🇸 United States

AMSafe® I.V. Administration Set

DI: 10704411006237 · 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
10704411006237
Version / Model
1
Catalog Number
1010001
Company Name
AMSINO INTERNATIONAL, INC.
Labeler DUNS
825673239
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-04-26
Public Version
4
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
b27f31ba-6273-4b38-9f45-e102b040fcb3

Device Description

AMSafe® I.V. Administration Set Non-Pyrogenic fluid pathway. GRAVITY USE ONLY 100" (254cm) Long

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 40704411006238
Primary 10704411006237