FDA UDI
In Commercial Distribution
🇺🇸 United States
Aveta Waste Management Accessory
DI: 00850006759149
·
Model: 205-224
·
MEDITRINA, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Aveta Waste Management Accessory
- Primary DI
- 00850006759149
- Version / Model
- 205-224
- Catalog Number
- 205-224
- Company Name
- MEDITRINA, INC.
- Labeler DUNS
- 080570262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-29
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 270097ac-0e0a-4d78-9b80-cd34af617bc2
Device Description
Aveta Waste Management Accessory for use with Aveta System
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58982 | Surgical tissue/fluid collection bag, non-sterile | A non-sterile flexible container (a pouch) designed to be attached adjacent to a site of surgical intervention to collect and store body fluids, tissue, or body parts (e.g., a limb) released during the procedure. It is typically constructed as a pouch made of plastic foils with an adhesive band for attachment (e.g., next to the patient's skin incision or on the sterile drape), is available in a variety of sizes, and may be equipped with a fluid filter. This device is not intended to connect to an active drainage system or suction system but relies on gravity for fluid collection. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850006759156 | GS1 | shelf carton | 6 | In Commercial Distribution | |
| Primary | 00850006759149 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190372 | 000 |