BD Insyte Autoguard 382623

GUDID 50382903826235

INSYTE AUTOG BC WING BLU 22GA X 1.0IN

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter

• Primary Device ID: 50382903826235
• NIH Device Record Key: 271458e7-5151-4a02-9d9c-be6063d26d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte Autoguard
• Version Model Number: 382623
• Catalog Number: 382623
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903826230 [Unit of Use]
GS1	30382903826231 [Primary]
GS1	50382903826235 [Package]; Contains: 30382903826231; 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
• 00382903814541: INSYTE AUTOGUARD GRAY 16GA X 1.16IN