OxSAT100

GUDID 07290016714463

S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD

Respiratory oxygen sensor

• Primary Device ID: 07290016714463
• NIH Device Record Key: 54a30200-5533-45e5-8418-1d3b2a31a305
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OxSAT100
• Version Model Number: 8110SA-300
• Company DUNS: 600632715
• Company Name: S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016714463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191574

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [OxSAT100]

• 07290016715774: 8110-S100A090
• 07290016715231: 8110S-300
• 07290016715224: 8110Y-090
• 07290016715200: 8110N-090
• 07290016715156: 8110S-090
• 07290016714609: 8110SP-200
• 07290016714555: 8118N300-Kit
• 07290016714548: 8118N090-Kit
• 07290016714531: 8118S300-Kit
• 07290016714524: 8118S090-Kit
• 07290016714517: 8118Y300-Kit
• 07290016714500: 8118Y090-Kit
• 07290016714487: 8110DP-300
• 07290016714470: 8110DP-090
• 07290016714463: 8110SA-300
• 07290016714456: 8110SA-090
• 07290016714425: 8110N-300
• 07290016714418: 8110Y-300
• 07290016714364: 811800
• 07290016714357: 811300