KIT, FLOYD CATH + BIODOME

GUDID 00817395023961

KIT, FLOYD CATH + BIODOME

PACKROOM LLC

Infant care kit

• Primary Device ID: 00817395023961
• NIH Device Record Key: 2fde24b3-7e89-4e60-af24-9fbd36ef1d72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KIT, FLOYD CATH + BIODOME
• Version Model Number: KT140
• Company DUNS: 015179820
• Company Name: PACKROOM LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817395023961 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-02
• Device Publish Date: 2024-06-24

Devices Manufactured by PACKROOM LLC

• 00817395024364 - Pack, Angio Hamilton: 2025-09-11 Pack, Angio Hamilton
• 00817395024357 - Kennestone Upper Extremity Pack: 2025-09-10 Kennestone Upper Extremity Pack
• 00817395024203 - Pack, Basic NEGA *RFID: 2025-04-17 Pack, Basic NEGA *RFID
• 00817395024067 - Kit, Kennestone Permacath: 2024-07-03 Kit, Kennestone Permacath
• 00817395024074 - Kit, Sub Extremity NEGA: 2024-07-03 Kit, Sub Extremity NEGA
• 00817395024081 - Kit, Ped Intub Blue 19-23kg NGHS: 2024-07-03 Kit, Ped Intub Blue 19-23kg NGHS
• 00817395024098 - Kit, Ped Nurse Blue 19-23kg NGHS: 2024-07-03 Kit, Ped Nurse Blue 19-23kg NGHS
• 00817395024104 - Kit, Ped Intub Green 30-36kg NGHS: 2024-07-03 Kit, Ped Intub Green 30-36kg NGHS