FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709022966 · Model: Z1340 · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical
Primary DI
00887709022966
Version / Model
Z1340
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
37ada4f4-a555-4f37-95e3-06b5b20dcf31

Device Description

128" (325 cm) Y-Type Blood Set with 170 Micron Fltr, Hand Pump, 2 Clave®, Remov 2 Gang (Blue, Yellow) 1o2® Manifold, Baseplate, 1 Ext, RL

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 10887709022963
Primary 00887709022966