Hopkins

GUDID 00817643023965

Replacement Neonate Wrap

MARKETLAB INC.

Pulse oximeter

• Primary Device ID: 00817643023965
• NIH Device Record Key: 83390056-8b9f-4a2f-8ca5-fc01e6bfc691
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hopkins
• Version Model Number: 138041
• Company DUNS: 848917027
• Company Name: MARKETLAB 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817643023965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172792

FDA Product Code

• DQA: Oximeter

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: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [Hopkins]

• 00817517026917: Hopkins Digital Baby Scale
• 00817643023965: Replacement Neonate Wrap
• 00817643023958: Pediatric Reusable Soft Probe
• 00817643023941: Hopkins Handheld Pulse Oximeter
• 00817643023934: Disposable Wrap Sensor (pk 10)
• 00817643023927: Adult Reusable Spring Clip Probe
• 00817643023972: Thermometer