FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Richard Wolf
DI: 00817984011195
·
Model: 0600-2160-000
·
MECTRA LABS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Richard Wolf
- Primary DI
- 00817984011195
- Version / Model
- 0600-2160-000
- Catalog Number
- 0600-2160-000
- Company Name
- MECTRA LABS, INC.
- Labeler DUNS
- 606939072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-29
- Public Version
- 2
- Public Version Date
- 2020-01-13
- Public Version Status
- Update
- Public Device Record Key
- 60d34bab-d821-4edb-85e4-6804cc96c6af
- Distribution End Date
- 2020-01-10
Device Description
Hand Pump
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
- Yes
- 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 |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37883 | General positive-pressure manual hand pump | A hand-operated manual device designed to draw in ambient air and expel the air from a connected nozzle to inflate an object, such as an inflatable mattresses or patient head support rings; it is not intended to be used with invasive devices. It is typically designed as a bicycle pump, a stirrup pump, or a large syringe-like pump, and may be used in the home or healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20817984011199 | GS1 | Case | 4 | Not in Commercial Distribution | 2020-01-10 |
| Primary | 00817984011195 | GS1 | ||||
| Package | 10817984011192 | GS1 | Inner pack | 5 | Not in Commercial Distribution | 2020-01-10 |
Customer Contacts
- Phone
- +1(800)323-3968
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 115 Degrees Fahrenheit