BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg 368033

GUDID 30382903680338

TUBE GLU PLH 13X75 4.0 PLBL GR BC

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic Evacuated blood collection tube IVD, anticoagulant/antiglycolytic

• Primary Device ID: 30382903680338
• NIH Device Record Key: ae0dbfd8-08c2-42ce-9c5b-26ee41dc0395
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg
• Version Model Number: 368033
• Catalog Number: 368033
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 100
• 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

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903680337 [Unit of Use]
GS1	30382903680338 [Primary]
GS1	50382903680332 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901449

FDA Product Code

• JKA: Tubes, vials, systems, serum separators, blood collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-04-05
• Device Publish Date: 2016-08-22

On-Brand Devices [BD Vacutainer® Sodium Fluoride/Potassium Oxalate 10mg/8mg]

• 30382903680338: TUBE GLU PLH 13X75 4.0 PLBL GR BC
• 30382903679226: TUBE GLU PLH 13X75 4.0 PLBL GR