PullUp Probe Cover Kit VPC5548PUC

GUDID 00841912100187

PROTEK MEDICAL PRODUCTS, INC.

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00841912100187
• NIH Device Record Key: 9b0f5c47-8d38-4fd3-912f-6ebe078075d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PullUp Probe Cover Kit
• Version Model Number: 2097
• Catalog Number: VPC5548PUC
• Company DUNS: 965417181
• Company Name: PROTEK MEDICAL PRODUCTS, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841912100187 [Primary]
GS1	10841912100184 [Package]; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970893

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [PullUp Probe Cover Kit]

• 10841912105653: 2211
• 10841912105363: 2295
• 00841912104475: 2097
• 10841912104359: 1512
• 10841912102867: 2231
• 10841912102874: 2231
• 10841912100627: 1096
• 10841912100382: 2233
• 10841912100375: 2233
• 10841912100368: 2231
• 10841912100207: 2099
• 00841912100194: 2099
• 00841912100187: 2097
• 10841912100177: 2097
• 00841912100163: 2097
• 10841912100153: 2096
• 00841912100149: 2095
• 10841912106735: 2048
• 10841912106315: 2044