ButtonHole NEEDLE SET

GUDID 10842289102535

NXSTAGE MEDICAL, INC.

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• Primary Device ID: 10842289102535
• NIH Device Record Key: 4e074d5e-a5c3-4025-9244-e9db56b6a00e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ButtonHole NEEDLE SET
• Version Model Number: BH-7015
• Company DUNS: 088013219
• Company Name: NXSTAGE 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com
• Phone: 1-866-697-8243
• Email: info@nxstage.com

Device Dimensions

• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch
• Needle Gauge: 15 Gauge
• Length: 1.25 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842289102538 [Primary]
GS1	10842289102535 [Package]; Contains: 00842289102538; Package: Shipping Box [250 Units]; In Commercial Distribution

FDA Product Code

• FIE: Needle, Fistula

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-29

On-Brand Devices [ButtonHole NEEDLE SET]

• 10842289102580: BH-7616
• 10842289102573: BH-7615
• 10842289102542: BH-7016
• 10842289102535: BH-7015
• 10842289102528: BH-7014