FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709023741 · Model: Z1646 · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical
Primary DI
00887709023741
Version / Model
Z1646
Company Name
ICU MEDICAL, INC.
Labeler DUNS
118380146
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-11-15
Public Version
5
Public Version Date
2020-11-19
Public Version Status
Update
Public Device Record Key
dc3880e3-608e-43d3-8abd-fc0d57c52f19

Device Description

88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave®, Rotating Luer w/Filter Cap

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
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
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

GMDN Terms

Code Name
38569 Blood transfusion set, non-exchange

Identifiers

Type ID
Package 10887709023748
Primary 00887709023741