FDA UDI Not in Commercial Distribution 🇺🇸 United States

K-SHIELD WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER

DI: 00646311400209 · Model: DBMS-23G · SB-KAWASUMI LABORATORIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
K-SHIELD WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER
Primary DI
00646311400209
Version / Model
DBMS-23G
Company Name
SB-KAWASUMI LABORATORIES, INC.
Labeler DUNS
690625850
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
8
Public Version Date
2024-01-26
Public Version Status
Update
Public Device Record Key
85db0311-b00a-4b95-9016-064c12b3582f
Distribution End Date
2022-01-08

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
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FMI Needle, Hypodermic, Single Lumen
FPA Set, Administration, Intravascular

GMDN Terms

Code Name
35209 Non-fixed blood collection needle

Identifiers

Type ID
Primary 00646311400209