Digitest™ D640E

GUDID 00810000520503

Digitest™ II Digital Pulptester

PARKELL, INC.

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• Primary Device ID: 00810000520503
• NIH Device Record Key: 78b59404-b37a-498f-8f8f-7d4f39665464
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digitest™
• Version Model Number: D640E
• Catalog Number: D640E
• Company DUNS: 009900424
• Company Name: PARKELL, 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com
• Phone: 6312491134
• Email: customerservice@parkell.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520503 [Primary]

FDA Product Code

• EAT: Tester, Pulp

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: 2018-10-15
• Device Publish Date: 2018-09-14

On-Brand Devices [Digitest™]

• 00810000520503: Digitest™ II Digital Pulptester
• 00810000520497: Digitest™ II Digital Pulptester
• M595D6400: Digitest™ II Digital Pulptester
• 00810000520862: Digitest™ 3 Digital Pulptester
• 00810000520657: Digitest™ II Digital Pulptester (Japan)