Pulse Oximeter

GUDID 00786511086398

SB BASIC PULSE OXIMETER-HPK-BX

RASHMAN CORPORATION

Pulse oximeter probe, reprocessed

• Primary Device ID: 00786511086398
• NIH Device Record Key: 210e5b3c-1500-4a81-bc0c-4abd6b06f4cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pulse Oximeter
• Version Model Number: SB456-HPK
• Company DUNS: 078803608
• Company Name: RASHMAN CORPORATION
• 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: 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	00786511086398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082641

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-07

On-Brand Devices [Pulse Oximeter]

• 00786511243159: FINGERTIP PULSE OXIMETER-PUW-BX
• 00786511243142: FINGERTIP PULSE OXIMETER-HKW-BX
• 00786511243135: FINGERTIP PULSE OXIMETER-BKW-BX
• 00786511086404: SB BASIC PULSE OXIMETER-PUR-BX
• 00786511086398: SB BASIC PULSE OXIMETER-HPK-BX
• 00786511086381: SB BASIC PULSE OXIMETER-CGY-BX
• 00786511086374: SB BASIC PULSE OXIMETER-BLK-BX
• 00786511083120: BASIC PULSE OXIMETER-CGY-BX
• 00786511075125: BASIC PULSE OXIMETER-PUR-BX
• 00786511075118: BASIC PULSE OXIMETER-HPK-BX
• 00786511072612: BASIC PULSE OXIMETER-BLK-BX