FDA UDI
In Commercial Distribution
🇺🇸 United States
MD Resource
DI: 00859898006065
·
Model: AFTD-Y
·
MEDICAL DEVICE RESOURCE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
Basic Information
- Brand Name
- MD Resource
- Primary DI
- 00859898006065
- Version / Model
- AFTD-Y
- Catalog Number
- AFTD-Y
- Company Name
- MEDICAL DEVICE RESOURCE CORPORATION
- Labeler DUNS
- 126830020
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-30
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0e98f9dc-db1d-4f26-aadd-f443aeea60cd
Device Description
AutoFuse Tubing Disposable, Y-Connection
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KGZ | Accessories, Catheter | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48138 | Dual spike connector | A sterile device designed with two separate spikes intended to connect (spike) two separate saline bags for simultaneous connection to a parent device. It typically consists of polyvinyl chloride (PVC) Y-shaped tubing with spikes at the proximal end and manually-operated clamps on both branches of the Y-piece and a connector at the distal end. It is typically used by hospital staff during a wound debridement process. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00859898006072 | GS1 | 6 | In Commercial Distribution | ||
| Package | 10859898006062 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00859898006065 | GS1 | ||||
| Package | 00859898006331 | GS1 | 5 | In Commercial Distribution | ||
| Package | 00859898006324 | GS1 | 4 | In Commercial Distribution | ||
| Package | 00859898006317 | GS1 | 3 | In Commercial Distribution | ||
| Package | 00859898006300 | GS1 | 2 | In Commercial Distribution |