FDA UDI
In Commercial Distribution
🇺🇸 United States
Bag Decanter
DI: 00813079020035
·
Model: 9001
·
REMINGTON MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bag Decanter
- Primary DI
- 00813079020035
- Version / Model
- 9001
- Catalog Number
- 9001
- Company Name
- REMINGTON MEDICAL, INC.
- Labeler DUNS
- 788472314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- e29e1b18-83ee-4331-9e6e-c5954f29d404
Device Description
For aseptic decanting of I.V. fluids from flexible containers.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHI | Set, i.V. Fluid transfer | General Hospital | 880.5440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60540 | Intravenous fluid bag spike | A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10813079020032 | GS1 | Shipping Carton | 50 | In Commercial Distribution | |
| Primary | 00813079020035 | GS1 |
Customer Contacts
- Phone
- +1(800)989-0057
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 15 | degree |