FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Medical Specialties, Inc.
DI: 00815849023185
·
Model: CMS-6479-R1
·
CUSTOM ASSEMBLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Custom Medical Specialties, Inc.
- Primary DI
- 00815849023185
- Version / Model
- CMS-6479-R1
- Company Name
- CUSTOM ASSEMBLIES, INC.
- Labeler DUNS
- 948904735
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 4
- Public Version Date
- 2021-07-19
- Public Version Status
- Update
- Public Device Record Key
- 0f42e44d-0599-4105-9553-31a36d25792b
Device Description
Custom Tubing Set w/ Multi-Step Connector - Sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPA | Set, Administration, Intravascular | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58977 | Basic intravenous administration set, noninvasive | A collection of noninvasive devices intended 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, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00815849023192 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00815849023185 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993463 | 000 |