FDA UDI In Commercial Distribution 🇺🇸 United States

BD Insyte Autoguard Shielded IV Catheter

DI: 00382903818129 · Model: 381812 · BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
BD Insyte Autoguard Shielded IV Catheter
Primary DI
00382903818129
Version / Model
381812
Catalog Number
381812
Company Name
BECTON, DICKINSON AND COMPANY
Labeler DUNS
124987988
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-10-22
Public Version
2
Public Version Date
2023-10-23
Public Version Status
Update
Public Device Record Key
80f99c56-4f0b-4c02-b366-bfc93ed5f576

Device Description

INSYTE AUTOGUARD YEL 24GA X .75IN

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
MR Conditional
Direct Marking Exempt
No
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
FOZ Catheter, intravascular, therapeutic, short-term less than 30 days

GMDN Terms

Code Name
64574 Peripheral intravenous cannula

Identifiers

Type ID
Package 30382903818120
Primary 00382903818129

Premarket Submissions

Submission Number Supplement Number
K201075 000