ULTRADRAPE 2 34-10

GUDID 20855683006962

Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in

PARKER LABORATORIES INC

Synthetic polymer semi-permeable film dressing, adhesive

• Primary Device ID: 20855683006962
• NIH Device Record Key: f7cc50a9-6e8b-4d34-82f4-3667660033aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRADRAPE 2
• Version Model Number: Ultrasound Guided Peripheral Intravenous Barrier a
• Catalog Number: 34-10
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com
• Phone: 9732769500
• Email: customerservice@parkerlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006968 [Unit of Use]
GS1	10855683006965 [Primary]
GS1	20855683006962 [Package]; Contains: 10855683006965; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• KGX: Tape And Bandage, Adhesive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

Devices Manufactured by PARKER LABORATORIES INC

• 20855683006962 - ULTRADRAPE 2: 2025-05-28Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in
• 20855683006962 - ULTRADRAPE 2: 2025-05-28 Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 4.68 in x 2.63 in
• 10303410000033 - Aquaflex: 2024-11-28 Profound 3cm narrow gel pad
• 10303410000026 - Aquaflex: 2024-09-05 Profound 3cm wide gel pad
• 10855683006347 - ECLIPSE: 2024-06-05 Eclipse Probe Cover-latex free, 64 mm / 44 x 241 mm
• 10855683006354 - ECLIPSE: 2024-06-05 Eclipse Probe Cover, 83mm/43x241mm
• 10855683006361 - AQUAGEL: 2024-06-05 Aquagel Lubricating Gel, 5 oz. tube
• 20855683006542 - Ultradrape: 2023-09-26 Ultrasound Guided Peripheral Intravenous Barrier and Securement Device 3.25''x5.8''
• 20855683006917 - BrainScope: 2023-09-26 Skin Prep Gel 5g