Kennestone AV Fistula

GUDID 00817395023282

Kennestone AV Fistula

PACKROOM LLC

General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00817395023282
• NIH Device Record Key: a93471af-5e3b-49b7-af47-a0aa8ddf9073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kennestone AV Fistula
• Version Model Number: WK120A
• 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	00817395023282 [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: 2022-07-22
• Device Publish Date: 2022-07-14

Devices Manufactured by PACKROOM LLC

• 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
• 00817395024111 - Kit, Ped Nurse Green 30-36kg NGHS: 2024-07-03 Kit, Ped Nurse Green 30-36kg NGHS
• 00817395024128 - Kit, Ped Intub Orange 24-29kg NGHS: 2024-07-03 Kit, Ped Intub Orange 24-29kg NGHS
• 00817395024135 - Kit, Ped Nurse Orange 24-29kg NGHS: 2024-07-03 Kit, Ped Nurse Orange 24-29kg NGHS