HEADSTAR

GUDID 04711402230488

HP93111I-3U Infant PVC Resuscitator Kit, includes: HP-9333A PVC Manual Resuscitator Bag - Infant x 1 pc HP-8401C #1 Air Cushion Mask x 1 pc HP-3306

HEADSTAR MEDICAL PRODUCTS CO., LTD.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04711402230488
• NIH Device Record Key: 0dca0283-7e06-4322-9116-c565f06780e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEADSTAR
• Version Model Number: HP93111I-3U
• Company DUNS: 658122049
• Company Name: HEADSTAR MEDICAL PRODUCTS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711402230488 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002846

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2017-10-17

On-Brand Devices [HEADSTAR]

• 04711402234226: HP-2558 Nebulizer Kit (Adult) includes: nebulizer bottle x 1pc, nebulizer mask (adult) x 1pc, ox
• 04711402234219: HP-2557 Nebulizer Kit (Child) includes: nebulizer bottle x 1pc, nebulizer mask (child), oxygen t
• 04711402234165: HP-2558 Nebulizer Kit(Child) includes: nebulizer bottle x 1pc, nebulizer mask(child) x 1pc, oxyg
• 04711402234158: HP-2557 Nebulizer Kit(Adult) includes: nebulizer bottle x 1pc, nebulizer mask(adult) x 1pc, oxyg
• 04711402230488: HP93111I-3U Infant PVC Resuscitator Kit, includes: HP-9333A PVC Manual Resuscitator Bag - Infa
• 04711402230471: HP93111C-3U Child PVC Resuscitator Kit, includes: HP-9833A PVC Manual Resuscitator Bag - Child
• 04711402230464: HP93111A-3U Adult PVC Resuscitator Kit, includes: HP-9511A PVC Manual Resuscitator Bag - Adult
• 04711402236077: REUSABLEDIVERTER, AUTOCLAVED TO 121 Degree C ( MATERIAL : PC ) Package: 250 PCS per PE BAG, 250
• 04711402235056: 7FT OXYGEN TUBING ONE PCS per PE BAG, 250 PCS per CS
• 04711402233021: VENTURI MASK KIT - CHILD CHILD NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) Pack
• 04711402233014: VENTURI MASK KIT - ADULT ADULT NEBULIZER MASK with 6 DILUTERS, HOOD AND OXYGEN TUBING (7FT) Pack
• 04711402230280: SILICONE RESUSCITATOR BAG ADULT With POP OFF (With HS Logo) AUTOCLAVE TO 121 Degree C MATERIAL
• 04711402233069: Headstar Tracheotomy mask comes in Child sizes and is designed to deliver oxygen and humidity to
• 04711402233052: Headstar Tracheotomy mask comes in adult sizes and is designed to deliver oxygen and humidity to