Halyard PS400X8-N

GUDID 30680651475214

ON-Q* Pain Relief System, On-Q Pump With Fixed Flow Rate, NRFit™ Connector

Avanos Medical, Inc.

Elastomeric infusion pump system

• Primary Device ID: 30680651475214
• NIH Device Record Key: b1f9a22f-f8df-4f6f-8345-40e4a1039f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Halyard
• Version Model Number: 47521
• Catalog Number: PS400X8-N
• Company DUNS: 079375431
• Company Name: Avanos Medical, 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: false
• 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

Customer Support Contacts

• Phone: +1(844)425-9273
• Email: PIQ@hyh.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10680651475210 [Primary]
GS1	30680651475214 [Package]; Contains: 10680651475210; Package: CS [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063530

FDA Product Code

• MEB: PUMP, INFUSION, ELASTOMERIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-08-10

On-Brand Devices [Halyard]

• 30680651997082: HALYARD* RF Probe, Curved-18-200-Black (Pink Stylet)
• 30680651986789: HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-18-145-Straight-Black-Black (Pink Sty
• 10680651125511: HALYARD* RF Probe, Curved-18-60-Black (Pink Stylet)
• 10680651125481: HALYARD* RF Probe, Straight-18-54-Black (Pink Stylet)
• 10680651125474: HALYARD* RF Probe, Curved-18-60-Black (Pink Stylet)
• 10680651125214: HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-18-200-Straight-Black-Black (Pink Sty
• 10680651125061: HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-20-60-Straight-Black-Yellow
• 10680651125023: HALYARD* RF Probe, Straight-20-60-Yellow
• 10680651111842: HALYARD* Radiofrequency Probes-Steam Sterilizable-Reusable-18-54-Straight-Black-Black (Pink Styl
• 30680651956805: HALYARD* MIC* Jejunostomy Feeding Port Adapter
• 30680651956799: HALYARD* MIC* Jejunostomy LUER-LOK* Caps
• 30680651795831: HYH,ANGIO,NSDRP,-,-,14
• 30680651795824: HYHL100 ANGIOGRAPHY DRAPE-NON-STERL 40
• 30680651791499: SURGICAL ANGIO DRAPE 14
• 30680651774140: ACMF UTILITY SHEETS 90" 40
• 30680651773501: CLVIEW CV-ART SPLDRP 1
• 30680651762192: ACMF CV OPRTNG PACK BLUE 2
• 30680651476457: ON-Q* Pain Relief System Convenience Kit with Tubing Sets
• 30680651476440: ON-Q* Pain Relief System Convenience Kit with SELECT-A-FLOW*, 400 ml, 2-14 ml/hr
• 30680651476068: ON-Q* Pain Relief System CONVENIENCE KIT with SELECT-A-FLOW*-400 ml -2-14 ml/hr
• 30680651447365: Repair Kit for EZstim* III
• 30680651447358: Mounting Bracket for EZstim* III
• 30680651392535: EZstim* III Peripheral Nerve Stimulator / Nerve Locator
• 30609038153798: HALYARD* Suction Valve and Y Adapter
• 30609038093094: HALYARD* Oral Care Suction Swab-25-Individual-Angled
• 30609038092998: Oral Care Suction Toothbrush
• 30609038002140: HALYARD* Flex Connector - Adult-Parallel "Y" with Adapter-Suction Canister
• 30609038000412: HALYARD* Suction Probe
• 30680651986062: HALYARD* Grounding Pad -- Dispersive Electrode
• 30680651970214: HALYARD* Oral Care 24-Hour Kit
• 30680651970207: HALYARD* Oral Care 24-Hour Kit
• 30680651949449: MIC-KEY* Threaded Extension Set, SECUR-LOK* Right Angle Connector and Clamp
• 30680651949432: MIC-KEY* Threaded Extension Set, SECUR-LOK* Right Angle Connector and Clamp
• 30680651938047: HALYARD* Saline Vials for Closed Suction Catheters-Inhalation USP
• 30680651501104: CLEAR-SITE* Alcohol-Free Anti-Fog Kit
• 30680651501098: CLEAR-SITE* Anti-Fog Kit
• 30680651474491: Assisted Care 24-Hour Oral Care Kit with Suction Tools with CHG (Mexico)
• 30680651474484: Assisted Care 24-Hour Oral Care Kit with Suction Tools (Mexico)
• 30680651473203: MIC-KEY* Single Port Feed Extension Set with ENFit® Connector, SECUR-LOK* Right Angle Connector
• 30680651473197: MIC-KEY* Single Port Feed Extension Set with ENFit® Connector, SECUR-LOK* Right Angle Connector
• 30680651470868: MIC-KEY* SF Single Port Extension Set with ENFit® Connector, Secure Flow Right Angle Connector,
• 30680651470844: MIC-KEY* SF Single Port Extension Set with ENFit® Connector, Secure Flow Right Angle Connector,
• 30680651469657: MIC-KEY* Bolus Feed Extension Set with ENFit® Connector, SECUR-LOK* Straight Connector, Bolus E
• 30680651452550: mini 24-Hour Oral Care Kit with BALLARD Technology, q4
• 20680651440697: MIC-KEY* Continuous Feed Extension Set with SECUR-LOK* Right Angle Connector, 2 Port "Y" and Cla
• 30680651440687: MIC-KEY* Bolus Feed Extension Set with ENFit® Connector, SECUR-LOK* Straight Connector, Bolus E
• 30680651440670: MIC-KEY* Continuous Feed Extension Set with ENFit® Connectors, SECUR-LOK* Right Angle Connector
• 30680651440663: MIC-KEY* Continuous Feed Extension Set with ENFit® Connectors, SECUR-LOK* Right Angle Connector
• 20680651440659: MIC-KEY* Continuous Feed Extension Set with SECUR-LOK* Right Angle Connector, 2 Port "Y" and Cla
• 20680651440642: MIC-KEY* Bolus Feed Extension Set with Cath Tip, SECUR-LOK* Straight Connector and Clamp, 30 cm