FDA UDI In Commercial Distribution 🇺🇸 United States

Integrated Medical Specialties

DI: 10868564000044 · Model: IMS033G · INTEGRATED MEDICAL SYSTEMS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
40

Basic Information

Brand Name
Integrated Medical Specialties
Primary DI
10868564000044
Version / Model
IMS033G
Company Name
INTEGRATED MEDICAL SYSTEMS, INC.
Labeler DUNS
962364444
Distribution Status
In Commercial Distribution
Device Count in Pkg
40
Record Status
Published
Publish Date
2017-03-17
Public Version
4
Public Version Date
2021-04-07
Public Version Status
Update
Public Device Record Key
2744276e-d52d-4897-8767-4f7c77bea03e

Device Description

IV ADMIN SET, W/ GVS EASYDROP® FLOW REGULATOR, DEHP-FREE, 1 Y-SITE, 15µ FILTER IN DRIP CHAMBER, SWIVEL LL, 92"

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
Primary 10868564000044
Unit of Use 00868564000047