FDA UDI
In Commercial Distribution
🇺🇸 United States
Aveta Roll Stand with Drape Pump
DI: 00850006759033
·
Model: 212-205
·
MEDITRINA, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aveta Roll Stand with Drape Pump
- Primary DI
- 00850006759033
- Version / Model
- 212-205
- Catalog Number
- 212-205
- Company Name
- MEDITRINA, INC.
- Labeler DUNS
- 080570262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-26
- Public Version
- 3
- Public Version Date
- 2023-10-04
- Public Version Status
- Update
- Public Device Record Key
- a38e7b29-8da1-46d7-922f-024c129e144d
Device Description
Aveta Roll Stand with Drape Pump
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | Obstetrics/Gynecology | 884.1700 | 2 |
| HIH | Hysteroscope (And Accessories) | Obstetrics/Gynecology | 884.1690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36664 | Basic roller pump | A mains electricity (AC-powered) pump using rotating rollers which squeeze a soft-walled tubing against the housing wall, thus producing a pulsatile pumping effect. It is typically used for the delivery of precise quantities of liquids (e.g., for laboratory devices and equipment). For the roller pump used in open heart surgery see the appropriate GMDN code. | No | Active |
| 42513 | Transportable medical equipment stand, non-powered | A non-powered (non-active) transportable device [e.g., on wheels or easily movable] designed to support medical equipment used for clinical purposes [e.g., in an operating room and/or an examination/treatment room]. It may include manually-adjustable articulated arms to enable dynamic positioning of equipment; the equipment to be supported is not included. The device does not include a battery pack but might include a battery holder and electrical connection wiring to feed power to medical equipment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850006759033 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190372 | 000 |