FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709044685 · Model: 42661-22 · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical
Primary DI
00887709044685
Version / Model
42661-22
Catalog Number
426610422
Company Name
ICU MEDICAL, INC.
Labeler DUNS
118380146
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-26
Public Version
1
Public Version Date
2021-09-03
Public Version Status
New
Public Device Record Key
f93224be-6633-41d7-aaaa-bc850d5ec2e3

Device Description

Transpac™ IV 15' Cable for use with Disposable Transducer

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DRS Transducer, blood-pressure, extravascular

GMDN Terms

Code Name
47487 Electrical-only medical device connection cable, reusable

Identifiers

Type ID
Primary 00887709044685

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K061573 000