Wipe Down Body Wedge w/Handle - Standard BPW04

GUDID 00810006680621

Wipe Down Body Wedge w/Handle - Standard (15” x 9” x 11”)

PRIMO INC

Freestanding patient positioner, reusable

• Primary Device ID: 00810006680621
• NIH Device Record Key: d52e131b-da28-4b33-91a4-56f72ff0b2ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wipe Down Body Wedge w/Handle - Standard
• Version Model Number: BPW04
• Catalog Number: BPW04
• Company DUNS: 958758146
• Company Name: PRIMO INC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00810006680232 [Primary]
GS1	00810006680621 [Package]; Contains: 00810006680232; Package: CASE [10 Units]; In Commercial Distribution

FDA Product Code

• FMP: Protector, Skin Pressure

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: 2019-03-11
• Device Publish Date: 2019-02-20

On-Brand Devices [Wipe Down Body Wedge w/Handle - Standard]

• 00810006682953: Wipe Down Body Wedge w/Handle, Firm - Standard (15”x9”x 11”)
• 00810006680621: Wipe Down Body Wedge w/Handle - Standard (15” x 9” x 11”)