Definition: To Store The External Peritoneal Catheter Portion Between Treatment Sessions And To Support, Stabilize, And Improve The Care And Cleanliness Of The Peritoneal Catheter And Reduce The Need To Use Tape On The Skin.
| Device Type ID | 2169 |
| Device Name | Garment, Storage, Peritoneal Dialysis Catheter |
| Physical State | Cloth Belt |
| Technical Method | Holds The Catheter Tube In A Cloth Sleeve Wrapped Around The Patient's Abdomen. |
| Target Area | External To The Body Around The Abdomen. |
| Regulation Description | Daily Activity Assist Device. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OAG |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2169 |
| Device | Garment, Storage, Peritoneal Dialysis Catheter |
| Product Code | OAG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Daily Activity Assist Device. |
| CFR Regulation Number | 890.5050 [🔎] |