FDA UDI In Commercial Distribution 🇺🇸 United States

Insyte Autoguard

DI: 00382903810475 · Model: 381047 · BECTON, DICKINSON AND COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1

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Basic Information

Brand Name
Insyte Autoguard
Primary DI
00382903810475
Version / Model
381047
Catalog Number
381047
Company Name
BECTON, DICKINSON AND COMPANY
Labeler DUNS
124987988
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-13
Public Version
1
Public Version Date
2026-02-23
Public Version Status
New
Public Device Record Key
7cf27fc7-eb76-4fee-a54a-6cf40a49a127

Device Description

BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 18 GA x 1.88 IN

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
Yes
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 30382903810476
Primary 00382903810475
Package 50382903810470

Premarket Submissions

Submission Number Supplement Number
K251654 000

Device Sizes

Type Value Unit Text
Length 48 Millimeter
Device Size Text, specify Flow Rate = 87 millilitre per minute (mL or ml/min)

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
Keep dry
Type
Special Storage Condition, Specify
Special Conditions
Keep away from sunlight
Type
Special Storage Condition, Specify
Special Conditions
Fragile, handle with care