Custom Medical Specialties, Inc.
- Primary DI
- 00815849022744
- Brand
- Custom Medical Specialties, Inc.
- Company
- CUSTOM ASSEMBLIES, INC.
- Model
- CMS-1211-NS
- Device description
- Single Spike Tumescent Set - Non-Sterile
- Published
- 2016-12-07
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| FPA | Set, Administration, Intravascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FPA | Set, Administration, Intravascular | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00815849020597 | Package | GS1 | 25 | In Commercial Distribution |
| 00815849022744 | Package | GS1 | 100 | In Commercial Distribution |
| 00815849020030 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00815849020597 | 00815849020597 | 815849020597 | 0815849020597 |
| 00815849022744 | 00815849022744 | 815849022744 | 0815849022744 |
| 00815849020030 | 00815849020030 | 815849020030 | 0815849020030 |
GMDN Terms
| Term | Definition |
|---|
| Intravenous administration set | A collection of noninvasive devices designed to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, clamps; the bag/bottle may be included. It does not include devices intended for invasive use nor a heat exchanger. This is a single-use device. |
Regulatory Flags
- DUNS number
- 948904735
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00815849024021 | Custom Medical Specialties, Inc. | CMS-2732-R4 | | 2023-09-14 |
| 00815849024571 | Custom Medical Specialties, Inc. | CMS-6314-R6 | | 2023-09-14 |
| 00815849023369 | Custom Medical Specialties, Inc. | CMS-1235 | | 2023-09-13 |
| 00815849023390 | Custom Medical Specialties, Inc. | CMS-1238 | | 2023-09-13 |
| 00815849023406 | PG-1000 | PG-1000 | | 2023-09-13 |
| 00815849023437 | Custom Assemblies, Inc. | CMS-2012-R3 | | 2023-09-13 |
| 00815849023444 | Custom Assemblies, Inc. | CMS-8322-R1 | | 2023-09-13 |
| 00815849023451 | Custom Medical Specialties, Inc. | CMS-5650-R2 | | 2023-09-13 |
| 00815849023468 | Custom Medical Specialties, Inc. | CMS-6382 | | 2023-09-13 |
| 00815849023475 | Custom Medical Specialties, Inc. | CMS-6439-C | | 2023-09-13 |
| 00815849023482 | MPM | MPM-312-R1 | | 2023-09-13 |
| 00815849023499 | Custom Medical Specialties, Inc. | CMS-1911-R3 | | 2023-09-13 |
| 00815849023505 | MPM | MPM-295 | | 2023-09-13 |
| 00815849023512 | Custom Medical Specialties, Inc. | CMS-2450-R4 | | 2023-09-13 |
| 00815849023529 | Custom Medical Specialties, Inc. | CMS-4439-R5 | | 2023-09-13 |
| 00815849023536 | Custom Medical Specialties, Inc. | CMS-6803-R1 | | 2023-09-13 |
| 00815849023543 | Custom Medical Specialties, Inc. | CMS-8963-R1 | | 2023-09-13 |
| 00815849023550 | Custom Medical Specialties, Inc. | CMS-6415-R1 | | 2023-09-13 |
| 00815849023567 | Custom Medical Specialties, Inc. | CMS-8522-R2 | | 2023-09-13 |
| 00815849023574 | Custom Medical Specialties, Inc. | CMS-4028-R5 | | 2023-09-13 |
Other Devices Sharing Product Codes