Primrose Medical, Inc

GUDID 00852323007040

Sub-Q ( subcutaneous ) Administration set, Safety

Primrose Medical Inc

Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle

• Primary Device ID: 00852323007040
• NIH Device Record Key: be809469-b0b2-4531-9ec2-6e2c37cd93aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primrose Medical, Inc
• Version Model Number: 900-5080
• Company DUNS: 617604392
• Company Name: Primrose Medical Inc
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852323007040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920537

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2022-11-02
• Device Publish Date: 2022-10-25

On-Brand Devices [Primrose Medical, Inc]

• 00852323007323: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007316: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007309: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007293: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007286: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007279: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007262: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007255: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007248: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007231: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007224: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007217: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007200: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007194: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007187: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007170: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007163: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007156: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007149: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007132: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007125: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007118: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007101: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007095: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007088: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007071: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007064: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007057: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007040: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007033: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007026: Sub-Q ( subcutaneous ) Administration set, Safety
• 00852323007002: Sub-Q ( subcutaneous ) Administration set, Safety