SmartPractice AL7004PP

GUDID 10854498007334

Finn Chambers on Scanpor 18mm PP, 100x1, 100/box

Smarthealth, Inc.

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• Primary Device ID: 10854498007334
• NIH Device Record Key: c3bfc1f6-27fe-48d9-b1ac-533a95b848b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartPractice
• Version Model Number: AL7004PP
• Catalog Number: AL7004PP
• Company DUNS: 061081477
• Company Name: Smarthealth, Inc.
• Device Count: 100
• 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: false
• 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: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com
• Phone: 1-800-878-3837
• Email: info@smartpractice.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854498007337 [Primary]
GS1	10854498007334 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013820

FDA Product Code

• LDH: System, Delivery, Allergen And Vaccine

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: 2020-12-10
• Device Publish Date: 2020-12-02

On-Brand Devices [SmartPractice]

• D766SP4400893: S/P STERILIZATION POUCH 2.75X10IN*200 658-03082
• D766407513: S/P POUCH SELF SEAL 5.25 X 10 *200 #SCMS
• D766407503: S/P POUCH SELF SEAL 3.5 X 9*200 #SCSS
• D766407443: S/P POUCH SELF SEAL 3.5 X 5.25 *200 #SCXSS
• D766SP4400692: MASK EARLP S/P FLUID RESIST PNK*50 #658-00311
• D766SP4400682: MASK EARLP S/P FLUID RESIST BL*50 #658-00310
• D766SP4400562: MASK EARLP S/P BL*50 #658-00060
• D766SP4400552: MASK EARLP S/P PNK*50 #658-00059
• 00854498007450: Finn Chamber AQUA, 8mm, 100x10
• 10854498007488: Finn Chambers on Scanpor ATOPY 12mm, 50X5, 50/box
• 10854498007358: Finn Chambers on Scanpor 12mm PP, 200x1, 200/box
• 10854498007341: Finn Chambers on Scanpor 12mm, 200x1, 200/box
• 10854498007334: Finn Chambers on Scanpor 18mm PP, 100x1, 100/box
• 10854498007228: Finn Chambers on Scanpor 8mm PP, 150x1, 150/box
• 10854498007198: Finn Chambers on Scanpor 8mm, 25x10, 25/box
• 10854498007174: Finn Chambers on Scanpor 8mm, 50x5 AL, 50/box
• 10854498007167: Finn Chambers on Scanpor 8mm PP, 100x10, 100/box
• 10854498007150: Finn Chambers on Scanpor 8mm, 100x10, 100/box
• 10854498007143: Finn Chambers on Scanpor OPEN 8mm, 50x10, 50/box
• 10854498007112: allergEAZE Clear Patch Test Chambers, 100X10
• 10854498007105: allergEAZE Patch Test Chambers, non-woven, 100X10
• 00854634003056: patchProtect, 100 sheets, Large
• 00854634003049: TruVol 20 microliter Precision Allergen Dispenser, 20-pack
• 00854634003032: patchProtect, 100 sheets, Small
• 00854634003025: patchProtect, 75 sheets, Assorted Pack (25 Small, 25 Medium, 25 Large)
• 00854498007054: patchProtect, 100 sheets, Medium
• 00854498007474: patchProtect, 25 sheets, Small
• 10854498007402: Finn Chamber Paper Discs, 8mm, 200/bag
• 00854498007399: Finn Chamber Paper Discs, 8mm, 1000/bag
• 10854498007389: Finn Chamber Paper Discs, 18mm, 100/bag
• 10854498007372: Finn Chamber Paper Discs, 12mm, 200/bag
• 10854498007365: Finn Chambers Loose Chambers 8mm, 1000/bag
• 10854498007266: Finn Chambers Loose Chambers 18 mm, 100/bag
• 10854498007242: Finn Chambers Loose Chambers 12mm, 200/bag
• 00854498007559: patchPrep tray Refill Kit
• 00854498007542: patchPrep tray Starter Kit
• 00854498007528: Universal Chamber Cover 50/box
• 00854498007085: patchTransport, 50 trays
• D766SP6941391: S/P TEMP C&B DBL A3.5+TIPS 658-00484
• D766SP6941381: S/P TEMP C&B DBL A2 +TIPS 658-00483
• D766SP6941371: S/P TEMP C&B DBL A1 +TIPS 658-00482