Infyna Chic
GUDID 00610075072682
Hydrophilic, single-use intermittent catheter
HOLLISTER INCORPORATED
Single-administration urethral drainage catheter| Primary Device ID | 00610075072682 |
| NIH Device Record Key | 74543485-9623-4375-9bbd-0809d4f2c587 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Infyna Chic |
| Version Model Number | 8110-30 |
| Company DUNS | 005527098 |
| Company Name | HOLLISTER INCORPORATED |
| Device Count | 30 |
| 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 |
Customer Support Contacts
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com | |
| Phone | +1(800)323-4060 |
| ccsecurestart@hollister.com |
Device Dimensions
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
| Catheter Length | 5 Inch |
| Catheter Gauge | 10 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00610075072651 [Primary] |
| GS1 | 00610075072682 [Unit of Use] |
| GS1 | 10610075072658 [Package] Contains: 00610075072651 Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191633
FDA Product Code
| GBM | Catheter, Urethral |
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 | 2021-02-09 |
| Device Publish Date | 2021-02-01 |
On-Brand Devices [Infyna Chic]
| 00610075072712 | Hydrophilic, single-use intermittent catheter |
| 00610075072705 | Hydrophilic, single-use intermittent catheter |
| 00610075072682 | Hydrophilic, single-use intermittent catheter |
| 00610075072644 | Hydrophilic, single-use intermittent catheter |
| 00610075072699 | Hydrophilic, single-use intermittent catheter |
Trademark Results [Infyna Chic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFYNA CHIC 88478368 not registered Live/Pending |
Hollister Incorporated 2019-06-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.