North American Rescue

GUDID 10842209114716

HRS, ZZ-0051, UNIV, 10EA NARP HEAT REFLECT SHELL,ZZ-0051, ARMY GREEN REINFORCED TFII

Encompass Group, L.L.C.

Hypothermia-prevention whole-body suit

• Primary Device ID: 10842209114716
• NIH Device Record Key: 3f708fa8-7dbb-4b4f-9ad8-949d2176d06d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: North American Rescue
• Version Model Number: 5170-300
• Company DUNS: 121788819
• Company Name: Encompass Group, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net
• Phone: 1-800-284-4540
• Email: compliance@encompassgroup.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842209114719 [Primary]
GS1	10842209114716 [Package]; Contains: 00842209114719; Package: CA [10 Units]; In Commercial Distribution

FDA Product Code

• KME: Bedding, Disposable, Medical

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: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [North American Rescue]

• 10842209119841: HRS-I, ZZ-1452, UNIV, 8EA NARP HEAT REFLECTIVE SHELL, INSULAT
• 10842209114716: HRS, ZZ-0051, UNIV, 10EA NARP HEAT REFLECT SHELL,ZZ-0051, ARM