Huckleberry

GUDID 20850045437637

Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Textured Blue M

Nephron Nitrile LLC

Nitrile surgical glove, non-powdered

• Primary Device ID: 20850045437637
• NIH Device Record Key: 5c7adfc2-0198-4540-9f89-9d1c4d010e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huckleberry
• Version Model Number: 200103003
• Company DUNS: 118398628
• Company Name: Nephron Nitrile LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850045437633 [Primary]
GS1	10850045437630 [Unit of Use]
GS1	20850045437637 [Package]; Contains: 00850045437633; Package: Case [10 Units]; In Commercial Distribution
GS1	30850045437634 [Package]; Package: Pallet [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231349

FDA Product Code

• LZA: Polymer Patient Examination Glove

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: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [Huckleberry]

• 20850045437637: Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Tex
• 20850045437668: Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Tex
• 20850045437651: Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Tex
• 20850045437644: Huckleberry Nitrile Powder-free Examination Polymer Coated Chemo & Fentanyl Tested Fingertip Tex
• 20850045437569: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap
• 20850045437552: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap
• 20850045437545: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap
• 20850045437538: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap
• 20850045437521: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap
• 20850045437514: Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherap