BD Insyte Autoguard 382557

GUDID 50382903825573

INSYTE AUTOG BC GRAY 16GA X 1.77IN

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter Peripheral vascular catheter Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula

• Primary Device ID: 50382903825573
• NIH Device Record Key: a20a19ce-e3e8-47f7-9523-76fdfc309095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte Autoguard
• Version Model Number: 382557
• Catalog Number: 382557
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903825578 [Unit of Use]
GS1	30382903825579 [Primary]
GS1	50382903825573 [Package]; Contains: 30382903825579; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110443
• Premarket Notification: K201075

FDA Product Code

• FOZ: Catheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [BD Insyte Autoguard]

• 50382903826570: INSYTE AUTOG BC WING GRAY 16GA X 1.77IN
• 50382903826549: INSYTE AUTOG BC WING GRAY 16GA X 1.16IN
• 50382903826471: INSYTE AUTOG BC WING GRN 18GA X 1.88IN
• 50382903826440: INSYTE AUTOG BC WING GRN 18GA X 1.16IN
• 50382903826372: INSYTE AUTOG BC WING PNK 20GA X1.88IN
• 50382903826341: INSYTE AUTOG BC WING PNK 20GA X1.16IN
• 50382903826334: INSYTE AUTOG BC WING PNK 20GA X 1.0IN
• 50382903826235: INSYTE AUTOG BC WING BLU 22GA X 1.0IN
• 50382903826129: INSYTE AUTOG BC WING YEL 24GA X .75IN
• 50382903825573: INSYTE AUTOG BC GRAY 16GA X 1.77IN
• 50382903825542: INSYTE AUTOG BC GRAY 16GA X 1.16IN
• 50382903825474: INSYTE AUTOG BC GRN 18GA X 1.88IN
• 50382903825443: INSYTE AUTOG BC GRN 18GA X 1.16IN
• 50382903825375: INSYTE AUTOG BC PNK 20GA X 1.88IN
• 50382903825344: INSYTE AUTOG BC PNK 20GA X 1.16IN
• 50382903825337: INSYTE AUTOG BC PNK 20GA X 1.0IN
• 50382903825238: INSYTE AUTOG BC BLU 22GA X 1.0IN
• 50382903825122: INSYTE AUTOG BC YEL 24GA X 0.75IN
• 50382903815574: INSYTE AUTOGUARD WINGED GRAY 16GA X 1.77
• 50382903815543: INSYTE AUTOGUARD WINGED GRAY 16GA X 1.16
• 50382903815475: INSYTE AUTOGUARD WINGED GN 18GA X 1.88IN
• 50382903815444: INSYTE AUTOGUARD WINGED GN 18GA X 1.16IN
• 50382903815376: INSYTE AUTOGUARD WINGED PNK 20GA X 1.88I
• 50382903815345: INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I
• 50382903815338: INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN
• 50382903815239: INSYTE AUTOGUARD WINGED BL 22GA X 1.0IN
• 50382903815123: INSYTE AUTOGUARD WINGED YEL 24GA X .75IN
• 50382903814676: INSYTE AUTOGUARD ORN 14GA X 1.75IN
• 50382903814577: INSYTE AUTOGUARD GRAY 16GA X 1.77IN
• 50382903814546: INSYTE AUTOGUARD GRAY 16GA X 1.16IN
• 50382903814478: INSYTE AUTOGUARD GN 18GA X 1.88IN
• 50382903814447: INSYTE AUTOGUARD GN 18GA X 1.16IN
• 50382903814379: INSYTE AUTOGUARD PNK 20GA X 1.88IN
• 50382903814348: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• 50382903814331: INSYTE AUTOGUARD PNK 20GA X 1.0IN
• 50382903814232: INSYTE AUTOGUARD BL 22GA X 1.0IN
• 50382903814126: INSYTE AUTOGUARD YEL 24GA X .75IN