Welch Allyn, Inc. 49020

GUDID 00732094072174

Welch Allyn Green Series LED Procedure Headlight; One White LED, 50 Lumens, 5,500° K; Rigid Headband; 120 V, 50-60 Hz AC, IEC Plug Type-B

WELCH ALLYN, INC.

Ophthalmic/otologic diagnostic set

• Primary Device ID: 00732094072174
• NIH Device Record Key: 9a7ac03a-a76d-4933-92b2-50583ae6aebc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Welch Allyn, Inc.
• Version Model Number: 901069
• Catalog Number: 49020
• Company DUNS: 198227881
• Company Name: WELCH ALLYN, 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com
• Phone: +1(315)685-2834
• Email: gdsn_support@MyHillRom.onmicrosoft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732094072174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031548

FDA Product Code

• FSR: Light, headband, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-17

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• 00732094238402: ELECTRODE RESTG AG AGCL 100 PK
• 00732094237795: Extra Large Cuff (40-54cm)
• 00732094237788: Extra Small Cuff (15-24cm)
• 00732094145717: CUFF TL ISO SOFT THIGH 2TUBE HP
• 00732094144024: DISPOSABLE ANO SHELF BOX
• 00732094225259: CUFF TL VINYL LARGE ADULT DBL BARREL
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• 00732094225341: CUFF TL SOFT ADULT LONG DBL BARREL
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• 00732094230499: ABPM-7100 Ambulatory Blood Pressure Monitor including Monitor Pouch, Adult Cuff, Adult Plus Cuff
• 00732094230505: 5MM TIPS WITH SLEEVE
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• 00732094222562: NOVAPLUS RAW CUFF SOFT SMALL ADULT
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• 00732094225433: CUFF TL REUSE ADULT DBL BARREL
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• 00732094128840: CUFF TL REUSE 2 PC THIGH 1TUBE ML
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• 00732094010237: CUFF TL REUSE 2 PC LG ADULT 1TUBE ML
• 00732094128765: CUFF TL REUSE 2 PC LG AD LONG 1TB LL
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• 00732094128642: CUFF TL REUSE 2 PC ADULT LONG 1TB ML
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• 00732094010015: CUFF TL REUSE 2 PC CHILD 1TUBE LL
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• 00732094009996: CUFF TL REUSE 2 PC CHILD 1TUBE ML