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Sign in to claim this brandCustomed, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- CALLE IGUALDAD No. 7, Fajardo, PR, 00738
- Website
- customedhealing.com
- —
- —
- [email protected]
- Phone
- 787-622-5151
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2648727
- DUNS Number
- 627572217
Catalogue (135)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633 | K974647 | FDA 510(k) | Class II | Active |
| Customed Cysto Pack Ii | K901705 | FDA 510(k) | Class II | Active |
| Customed Lap Pack Ii | K902191 | FDA 510(k) | Class II | Active |
| Prep Shave Kit (non-Sterile) | K925016 | FDA 510(k) | Class II | Active |
| Urinary Drainage Bag, (reorder No. 0749 - Product No. 900-749) | K962652 | FDA 510(k) | Class II | Active |
| Customed Cardiovascular Pack | K904693 | FDA 510(k) | Class II | Active |
| Blood Gas Kit (non-Sterile) Reorder No. 0560 | K930986 | FDA 510(k) | Class I | Active |
| O. B. Pack I | K902271 | FDA 510(k) | Class I | Active |
| Customed Hip Pact | K903336 | FDA 510(k) | Class II | Active |
| O. B. Pack Iii | K902273 | FDA 510(k) | Class I | Active |
| Customed Arthroscopy Pack | K902887 | FDA 510(k) | Class II | Active |
| Customed Cysto Pack I | K902274 | FDA 510(k) | Class II | Active |
| Customed Basic Pack Iii | K902886 | FDA 510(k) | Class II | Active |
| Irrigation Tray W/ Bulb Syringe | K924809 | FDA 510(k) | Class I | Active |
| O. B. Pack Ii | K902272 | FDA 510(k) | Class I | Active |
| Customed Blood Extraction Kit | K962596 | FDA 510(k) | Class II | Active |
| Customed Lap Pack I | K902029 | FDA 510(k) | Class II | Active |
| Suction Catheter Tray Product No. 900277 | K964011 | FDA 510(k) | Class II | Active |
| Tpn Tray (sterile) | K925021 | FDA 510(k) | Class II | Active |
| Iv Prep Kit W/O Dressing (non-Sterile) | K925018 | FDA 510(k) | Class II | Active |
| Customed Lap Pack Iii | K902030 | FDA 510(k) | Class II | Active |
| Customed Basic Pack I | K902884 | FDA 510(k) | Class II | Active |
| O. B. Pack Iv | K902032 | FDA 510(k) | Class II | Active |
| Customed Angiodrape Pack Femoral | K904694 | FDA 510(k) | Class II | Active |
| Iv Prep Kit (non-Sterile) | K925017 | FDA 510(k) | Class II | Active |
| Wound Closure/Laceration Tray | K950295 | FDA 510(k) | Class II | Active |
| Foley Catheterization Tray | K942177 | FDA 510(k) | Class II | Active |
| Customed Lap Pack Iv | K902031 | FDA 510(k) | Class II | Active |
| Customed Basic Pack Ii | K902885 | FDA 510(k) | Class II | Active |
| Customed Orthopedic Ii | K902888 | FDA 510(k) | Class II | Active |
| Surgical Tray (sterile) | K925022 | FDA 510(k) | Class I | Active |
| Tracheostomy Care Kit (sterile) | K925020 | FDA 510(k) | Class II | Active |
| Universal Drainage Tray | K961442 | FDA 510(k) | Class II | Active |
| Sterimed Sterization Wrapper (non-Sterile) | K953678 | FDA 510(k) | Class II | Active |
| Gown Poly Reinforced Large(product No.900-522)/(reorder No. 0522) | K971920 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- CustoMED Ltd IL