Kendall

GUDID 30817357022064

Kendall SCD Thigh Length, Medium

HYGIA HEALTH SERVICES, INC.

Multi-chamber venous compression system garment, reprocessed

• Primary Device ID: 30817357022064
• NIH Device Record Key: 8e69cc8e-020a-4a52-b8e8-4834004a9df5
• Commercial Distribution Discontinuation: 2019-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Kendall
• Version Model Number: 5330
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357022060 [Primary]
GS1	30817357022064 [Package]; Contains: 10817357022060; Package: Box [5 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012417

FDA Product Code

• JOW: Sleeve, Limb, Compressible

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-03-19
• Device Publish Date: 2016-09-24

On-Brand Devices [Kendall]

• 30817357022064: Kendall SCD Thigh Length, Medium
• 30817357022033: Kendall SCD Thigh Length, Large
• 30817357022019: Kendall ImPad Rigid Sole Foot Covers Lg. Pair
• 30817357021975: Kendall SCD Comfort Knee Length Small
• 30817357021906: Kendall SCD Express Knee Length, Extra Large
• 30817357021890: Kendall SCD Express Thigh Length, Large
• 30817357021692: Kendall ImPad Rigid Sole Foot Covers Reg. Pair
• 30817357021654: Kendall SCD Express Tear-Away Thigh Length, Medium
• 30817357021449: Kendall SCD Comfort Knee Length Large
• 30817357021364: Kendall SCD Express Thigh Length, Small
• 30817357021227: Kendall SCD Foot Cuff, Large
• 30817357021210: Kendall SCD Express Thigh Length, Medium
• 30817357021036: Kendall SCD Foot Cuff, Regular
• 30817357020992: Kendall SCD Express Knee Length, Large
• 30817357020930: Kendall SCD Knee Length, Medium
• 30817357020404: Kendall SCD Comfort Knee Length Medium
• 30817357020169: Kendall SCD Express Knee Length, Medium