FDA UDI In Commercial Distribution 🇺🇸 United States

Insyte Autoguard

DI: 00382903819447 · Model: 381944 · 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
00382903819447
Version / Model
381944
Catalog Number
381944
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
8f8972c5-1e62-41cd-9d2e-fee53a498d94

Device Description

BD Insyte™ Autoguard™ Winged Shielded IV Catheter 18 GA x 1.16 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 30382903819448
Primary 00382903819447
Package 50382903819442

Premarket Submissions

Submission Number Supplement Number
K251654 000

Device Sizes

Type Value Unit Text
Device Size Text, specify Flow Rate = 105 millilitre per minute (mL or ml/min)
Length 30 Millimeter

Storage Conditions

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