FDA UDI
In Commercial Distribution
🇺🇸 United States
MD Resource
DI: 00859898006409
·
Model: AV2000D
·
MEDICAL DEVICE RESOURCE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
7
Pkg Device Count
1
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Basic Information
- Brand Name
- MD Resource
- Primary DI
- 00859898006409
- Version / Model
- AV2000D
- Catalog Number
- AV2000D
- Company Name
- MEDICAL DEVICE RESOURCE CORPORATION
- Labeler DUNS
- 126830020
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-08
- Public Version
- 8
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 63377458-11c0-447f-97c7-791dbfc58fc2
Device Description
Aquavage 2000cc
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | General Hospital | 880.6960 | 1 |
| MUU | System, Suction, Lipoplasty | General, Plastic Surgery | 878.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34858 | Surgical suction system collection container, single-use | A sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 70859898006408 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 00859898006409 | GS1 | ||||
| Package | 60859898006401 | GS1 | 6 | In Commercial Distribution | ||
| Package | 50859898006404 | GS1 | 5 | In Commercial Distribution | ||
| Package | 40859898006407 | GS1 | 4 | In Commercial Distribution | ||
| Package | 30859898006400 | GS1 | 3 | In Commercial Distribution | ||
| Package | 20859898006403 | GS1 | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 510-732-9950
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092284 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius