nimbl

GUDID 00816305024708

DEMO Arm Long PD08-N1

Tactile Systems Technology, Inc.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00816305024708
• NIH Device Record Key: f35fd305-690c-4b4e-9d91-2b4b13562730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nimbl
• Version Model Number: DS PL-AR-LO-LR
• 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

Customer Support Contacts

• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com
• Phone: +1-833-382-2845
• Email: customerservice@tactilemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305024708 [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: 2024-08-13
• Device Publish Date: 2024-08-05

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