FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709045408 · Model: 42773-36 · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical
Primary DI
00887709045408
Version / Model
42773-36
Catalog Number
42773-36
Company Name
ICU MEDICAL, INC.
Labeler DUNS
118380146
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-10-26
Public Version
1
Public Version Date
2021-11-03
Public Version Status
New
Public Device Record Key
04fbc87d-af49-48a8-9919-87d6d1ed8f99

Device Description

Transpac™ IV 10' 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
No
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 00887709045408

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K061573 000