Harmony Polyisoprene Single Sleeve REV C

GUDID 00628347062774

Pamco Distributing Inc

Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer Female condom, synthetic polymer

• Primary Device ID: 00628347062774
• NIH Device Record Key: 57793a1f-07ca-46ea-b4d9-1a5e3bf61006
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony Polyisoprene Single Sleeve
• Version Model Number: HA-101-INS
• Catalog Number: REV C
• Company DUNS: 208394130
• Company Name: Pamco Distributing 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628347062774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203727

FDA Product Code

• MSC: Barrier, Std, Oral Sex

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: 2024-06-07
• Device Publish Date: 2024-05-30

Devices Manufactured by Pamco Distributing Inc

• 00628347062736 - Harmony Latex Single Sleeve: 2024-06-07
• 00628347062774 - Harmony Polyisoprene Single Sleeve: 2024-06-07
• 00628347062774 - Harmony Polyisoprene Single Sleeve: 2024-06-07
• 00628347062729 - Harmony Latex Dam Bulk Box: 2024-04-02 Harmony Latex Dam Bulk Box 100/box
• 00628347065881 - Harmony Polyisoprene Dam Retail Pack: 2024-04-02 Harmony Polyisoprene Dam Retail Pack 6/pack
• 00628347069810 - Harmony Latex Dam Retail Pack: 2024-04-02 Harmony Latex Dam Retail Pack 6/pack
• 00860003804544 - Harmony Polyisoprene Dams Bulk Box: 2022-02-25 Harmony Polyisoprene Dams Bulk Box of 60.
• 00860003804513 - Harmony Latex Dam Bulk Box: 2022-02-25 Harmony Latex Dam Bulk Box 100/box
• 00860003804520 - Harmony Polyisoprene Dam Retail Pack: 2022-02-25 Harmony Polyisoprene Dam Retail Pack 6/pack