FDA UDI In Commercial Distribution 🇺🇸 United States

ICU Medical

DI: 00887709078024 · Model: KCAP-A · ICU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
ICU Medical
Primary DI
00887709078024
Version / Model
KCAP-A
Catalog Number
KCAP-A
Company Name
ICU MEDICAL, INC.
Labeler DUNS
118380146
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-08-30
Public Version
1
Public Version Date
2023-09-07
Public Version Status
New
Public Device Record Key
2ab81a8c-a28a-4ca3-9ca7-7e51933419c7

Device Description

Drainage Catheter Syringe Adapter

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
Yes
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
GCE ADAPTOR, CATHETER

GMDN Terms

Code Name
60538 Luer/Luer linear connector, single-use

Identifiers

Type ID
Package 10887709078021
Primary 00887709078024

Customer Contacts