RESUSCITATION KIT

GUDID 00848530105037

Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8100H, 1SBC01M, 1SBC01L, RES8205B, 1 RES8201L, 1 BF2200

SUNSET HEALTHCARE SOLUTIONS, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00848530105037
• NIH Device Record Key: 6beb69b4-8407-4693-9d55-fae560dd1fec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESUSCITATION KIT
• Version Model Number: RES8500
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530105037 [Primary]
GS1	10848530105034 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• CAE: Airway, Oropharyngeal, Anesthesiology

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: 2025-08-28
• Device Publish Date: 2025-08-20

On-Brand Devices [RESUSCITATION KIT]

• 00848530105044: Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit con
• 00848530105037: Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8
• 00848530104993: Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs