FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 00650862199093
·
Model: 19909
·
Atrium Medical Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00650862199093
- Version / Model
- 19909
- Company Name
- Atrium Medical Corporation
- Labeler DUNS
- 051798999
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 6
- Public Version Date
- 2021-10-12
- Public Version Status
- Update
- Public Device Record Key
- acf23693-9ccb-4875-b187-7bf360a86fb2
- Distribution End Date
- 2021-10-01
Device Description
Y-EXTENSION SET, FOR 2-DRAINS, 3/8
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
- 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 |
|---|---|---|---|---|
| KDQ | BOTTLE, COLLECTION, VACUUM | General Hospital | 880.6740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45389 | Closed-wound drain connector | A tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20650862199097 | GS1 | 10 | Not in Commercial Distribution | 2021-10-01 | |
| Primary | 00650862199093 | GS1 |