Nimbl 703434-002

GUDID 00816305024876

PD08-N1 Bilateral Controller

Tactile Systems Technology, Inc.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00816305024876
• NIH Device Record Key: 8651bb53-726d-4eae-a67c-8e32988423e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbl
• Version Model Number: PD08-N1
• Catalog Number: 703434-002
• Company DUNS: 146295980
• Company Name: Tactile Systems Technology, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305024876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234155

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-10
• Device Publish Date: 2025-02-28

On-Brand Devices [Nimbl]

• 00816305024715: DEMO Arm Short PD08-N1
• 00816305024708: DEMO Arm Long PD08-N1
• 00816305024678: PD08-N1 Controller
• 00816305024661: PD08-N1 Battery
• 00816305024654: Arm, Long
• 00816305024647: Arm, Short
• 00816305024883: Assembly, Power Adapter
• 00816305025002: PD08-N1 Reconditioned Controller
• 00816305024999: Full Leg Extender, Long
• 00816305024982: Full Leg Extender, Short
• 00816305024975: Half Leg
• 00816305024968: Connector Assembly
• 00816305024951: Bilateral Adapter, Long
• 00816305024944: Bilateral Adapter, Short
• 00816305024876: PD08-N1 Bilateral Controller
• 00816305024869: Full Leg Long, Right
• 00816305024852: Full Leg Long, Left
• 00816305024845: Full Leg Short, Right
• 00816305024838: Full Leg Short, Left
• 00816305025071: Demo Stock - Half Leg Garment, PD08-N1
• 00816305025095: Nimbl Travel Bag