Green Sprouts 222392

GUDID 30715418091144

Cool Hand Teether 2pk-Boy's Set-3mo+

I PLAY. INC.

Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled Teething device, fluid-filled

• Primary Device ID: 30715418091144
• NIH Device Record Key: fddab2c4-272c-4666-b955-c97ed686e514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Green Sprouts
• Version Model Number: 222392-906-33
• Catalog Number: 222392
• Company DUNS: 131904450
• Company Name: I PLAY. INC.
• Device Count: 2
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00715418091143 [Primary]
GS1	10715418091133 [Unit of Use]
GS1	20715418091147 [Package]; Contains: 00715418091143; Package: Poly Bag [6 Units]; In Commercial Distribution
GS1	30715418091144 [Package]; Contains: 20715418091147; Package: Carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093370

FDA Product Code

• KKO: Ring, Teething, Fluid-Filled

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: 2016-09-15

On-Brand Devices [Green Sprouts]

• 00715418095172: Cooling Teether-Purple Grape-3mo+
• 30715418091144: Cool Hand Teether 2pk-Boy's Set-3mo+
• 30715418091137: Cooling Teether (2pk)-Pink Set Set-3mo+
• 30715418028591: 222340-287-33
• 30715418020359: Cooling Teether-Clear-3mo+
• 00715418179889: Cool Nature Teether - Assorted
• 00715418179001: Cool Nature Teether - Yellow/Aqua Set
• 00715418178998: Cool Nature Teether - Green/Aqua Set
• 00715418174730: Cool Ring Teether (2 pack) Clear - 6mo+
• 00715418176833: Sprout Ware® Nasal Aspirator made from Plants and Silicone-Tube-Green-Adult Use Only
• 00715418176826: Sprout Ware® Nasal Aspirator made from Plants and Silicone-Bulb-Green-Adult Use Only
• 00715418176055: Digital Thermometer-Green-Adult Use Only
• 00715418154893: Silicone Fruit Teether-Assorted-3mo+
• 00715418154756: Silicone Fruit Teether-Blueberry-3mo+
• 00715418154749: Silicone Fruit Teether-Banana-3mo+
• 00715418154732: Silicone Fruit Teether-Apple-3mo+
• 00715418154725: Silicone Fruit Teether-Strawberry-3mo+
• 00715418147284: Learning Toothbrush -Aqua-9-18 mo
• 00715418147277: Learning Toothbrush -Green-9-18 mo
• 00715418147260: Learning Toothbrush -Pink-9-18 mo
• 00715418147253: Learning Toothbrush -Assorted-9-18 mo
• 00715418147246: Front & Side Teether-Green-6mo+
• 00715418147161: Molar Teether-Aqua-12mo+
• 00715418088655: Everyday Teethers made from Silicone (2 pack)-Blue Set
• 00715418088648: Everyday Teethers made from Silicone (2 pack)-Pink Set
• 00715418088495: Everyday Teethers made from Silicone (2 pack)-Assorted
• 00715418028606: Cool Fruit Teether-Green Apple-3mo+
• 00715418022956: First Toothbrush made from Silicone-Clear
• 00715418020341: Cool Fruit Teether-Assorted-3mo+
• 00715418174136: Teether Toothbrush -Clear-6-12 mo
• 00715418163499: First Teethers made from Silicone (3pk)-Assorted-3mo+
• 00715418163475: Muslin Stay-dry Teether Bibs made from Organic Cotton (3pk)-White-0/12mo
• 00715418163468: Muslin Snuggle Blankie Teether made from Organic Cotton-Blue Owl-0mo+
• 00715418163451: Muslin Snuggle Blankie Teether made from Organic Cotton-Pink Bunny-0mo+
• 00715418163444: Muslin Snuggle Blankie Teether made from Organic Cotton-Aqua Fox-0mo+
• 00715418163437: Muslin Snuggle Blankie Teether made from Organic Cotton-Gray Koala-0mo+
• 00715418163420: First Teethers made from Silicone (3pk)-Aqua Set-3mo+
• 00715418163413: First Teethers made from Silicone (3pk)-Pink Set-3mo+
• 00715418163369: Muslin Stay-dry Teether Bibs made from Organic Cotton (3pk)-Blue Owl-0/12mo
• 00715418163352: Muslin Stay-dry Teether Bibs made from Organic Cotton (3pk)-Pink Bunny-0/12mo
• 00715418163345: Muslin Stay-dry Teether Bibs made from Organic Cotton (3pk)-Aqua Fox-0/12mo
• 00715418163253: Muslin Stay-dry Teether Bibs made from Organic Cotton (3pk)-Gray Koala-0/12mo
• 00715418156316: Flexible Sunglasses-Pink-2T/4T
• 00715418156309: Flexible Sunglasses-Pink-0/24mo
• 00715418156163: Sunglasses-Assorted-0/24mo
• 00715418156149: Sunglasses-Assorted-2T/4T
• 00715418155388: Flexible Sunglasses-Black-2T/4T
• 00715418155371: Flexible Sunglasses-Black-0/24mo
• 00715418155364: Flexible Sunglasses-Aqua-2T/4T
• 00715418155357: Flexible Sunglasses-Aqua-0/24mo