AMXOR Imperative 3-Layer SMS Jacket

GUDID 00850049248082

AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Pink

Amxor Healthcare LLC

Professional examination gown, single-use

• Primary Device ID: 00850049248082
• NIH Device Record Key: 58bd848f-a633-4614-9d88-9453d8ffcc32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMXOR Imperative 3-Layer SMS Jacket
• Version Model Number: AJ-PKS
• Company DUNS: 124112849
• Company Name: Amxor Healthcare LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049248075 [Primary]
GS1	00850049248082 [Package]; Contains: 00850049248075; Package: Package [10 Units]; In Commercial Distribution
GS1	10850049248072 [Unit of Use]
GS1	10850049248089 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Gown

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: 2024-03-21
• Device Publish Date: 2024-03-13

On-Brand Devices [AMXOR Imperative 3-Layer SMS Jacket]

• 00850049248303: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size X-Large, Ceil Blue
• 00850049248280: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size X-Large, Purple
• 00850049248266: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size X-Large, Pink
• 00850049248242: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Large, Ceil Blue
• 00850049248228: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Large, Purple
• 00850049248204: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Large, Pink
• 00850049248181: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Ceil Blue
• 00850049248167: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Purple
• 00850049248143: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Pink
• 00850049248105: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Purple
• 00850049248082: AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Pink