Hopkins Medical Products® 550243

GUDID 00817643020339

Ambu Resuscitation Mask Infant

HOPKINS UNIFORM COMPANY

Resuscitator face mask, single-use

• Primary Device ID: 00817643020339
• NIH Device Record Key: af3f9246-0861-44ff-a8d7-42aae7868816
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hopkins Medical Products®
• Version Model Number: 550243
• Catalog Number: 550243
• Company DUNS: 003080678
• Company Name: HOPKINS UNIFORM COMPANY
• 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: true
• 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: true

Customer Support Contacts

• Phone: +1(800)835-1995
• Email: customerservice@hopkinsmedical.net
• Phone: +1(800)835-1995
• Email: customerservice@hopkinsmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817643020339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970688

FDA Product Code

• KGB: MASK, OXYGEN, NON-REBREATHING

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: 2018-10-29
• Device Publish Date: 2018-09-28

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• 00817643022500: MRSA Plus Kit Small Adult
• 00817643022494: Lubricating Jelly 3gm Each
• 00817643022487: Individual 10 inchx10 inch Bio Bag
• 00817643022470: Individual 6 inchx10 inch Bio Bag
• 00817643022463: CaviWipes Bleach 10.5 inch x 6 inch, 90 Wipes/Canister
• 00817643022456: Chemo Spillt Kit
• 00817643022449: Cavicide 24oz
• 00817643022432: Cavicide 8oz
• 00817643022425: CaviCide 2oz
• 00817643022418: Bio-Hazard Red Bag
• 00817643022401: Germicidal Wipe Super SaniCloth
• 00817643022388: Code Blue Latex Gloves X-Large 500/PK
• 00817643022371: Code Blue Latex Gloves Small 500/PK
• 00817643022364: Code Blue Latex Gloves Medium 500/PK
• 00817643022357: Code Blue Latex Gloves Large 500/PK
• 00817643022340: Code Blue Latex Gloves X-Large 50/PK
• 00817643022333: Code Blue Latex Gloves Small 50/PK
• 00817643022326: Code Blue Latex Gloves Large 50/PK
• 00817643022319: CaviWipesXL 10” x 12” 50 Individual Packets/Box
• 00817643022302: CaviWipesXL 10” x 12” 66 Wipes/Canister
• 00817643022296: CaviWipes 6” x 6.75” 160 Wipes/Canister
• 00817643022289: CaviWipes 6” x 6.75” 220 Wipes/Canister
• 00817643022272: Bouffant Cap Each
• 00817643022265: Personal Protection Gown with Thumb Loop
• 00817643022258: Instant Heat Pack
• 00817643022241: Micropore Tape 1 inch Kit/EA
• 00817643022234: Adhesive Bandage 3/4 inchx3 inch Each
• 00817643022227: Flexible Adhesive Bandage 1 inchx3 inch 100/PK
• 00817643022210: 4 inch Stretch Conforming Bandage 12/pk
• 00817643022203: 3 inch Stretch Conforming Bandage 12/pk
• 00817643022197: Sterile Gauze Sponges 4 inch X 4 inch 25/PK
• 00817643022180: 5 inch x 9 inch Sterile Dressing 20/PK (20 packs per case)
• 00817643022173: 8 ply Sterile Gauze Sponges 2 inch X 2 inch 100/PK
• 00817643022166: Foam Wound Measure Stick, Sterile 50/PK
• 00817643022159: Small Finger Tip Adhesive Bandage 100/PK
• 00817643022142: Adhesive Bandage 3/4 inch X 3 inch 100/PK
• 00817643022135: Surgical Tape Transparent 2 inchx10yds
• 00817643022128: OneStep+ Lancet 2.8mm Pink 100/PK
• 00817643022111: OneStep+ Lancet 2.2mm Orange 100/PK
• 00817643022104: OneStep+ Lancet 1.8mm Grey 100/PK
• 00817643022098: One-Step + Lancet 1.8mm Green 100/PK
• 00817643022081: Nitrile Gloves, X-Large 100/PK
• 00817643022074: Nitrile Gloves, Small 100/PK
• 00817643022067: Nitrile Gloves, Medium 100/PK
• 00817643022050: Nitrile Gloves, Large 100/PK
• 00817643022043: Halyard Purple Nitrile Exam Gloves Small Box 100
• 00817643022036: Halyard Purple Nitrile Exam Gloves Medium Box 100
• 00817643022029: Junior Non-sterile Tongue Depressor 500/PK
• 00817643022012: Powder Free Latex Gloves Small 100/PK