FDA UDI
In Commercial Distribution
🇺🇸 United States
Vermed
DI: 00009336006540
·
Model: SHRP18 GAL CHEMO W/PORT/DUO LID
·
GRAPHIC CONTROLS ACQUISITION CORP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Vermed
- Primary DI
- 00009336006540
- Version / Model
- SHRP18 GAL CHEMO W/PORT/DUO LID
- Catalog Number
- 32028117
- Company Name
- GRAPHIC CONTROLS ACQUISITION CORP
- Labeler DUNS
- 002111896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-24
- Public Version
- 4
- Public Version Date
- 2023-08-18
- Public Version Status
- Update
- Public Device Record Key
- 8f7e40de-19a1-498c-ac98-96e71ddc8ec1
Device Description
SHRP18 GAL CHEMO W/PORT/DUO LID
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MMK | Container, Sharps | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36021 | Cytotoxic waste container | A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of cytotoxic materials (e.g., chemotherapy/antineoplastic drugs). It is typically used with a liner or a sealed leak proof bag, and has a lid for that allows temporary and final closure options; the lid typically includes a seal to prevent leakage. It is identified with a cytotoxic biohazard symbol on its labelling and sent to an appropriate waste treatment plant for disposal when filled to the recommended level. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 70009336006549 | GS1 | Pallet | 16 | In Commercial Distribution | |
| Package | 50009336006545 | GS1 | Case | 7 | In Commercial Distribution | |
| Primary | 00009336006540 | GS1 |
Customer Contacts
- Phone
- 800-669-6905
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071517 | 000 |