FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro-Fit
DI: 07540198000336
·
Model: Regular Speculum Pack with stop disc
·
Prime Pacific Health Innovations Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Pro-Fit
- Primary DI
- 07540198000336
- Version / Model
- Regular Speculum Pack with stop disc
- Catalog Number
- 8115
- Company Name
- Prime Pacific Health Innovations Corporation
- Labeler DUNS
- 250896255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 5
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- 4e00f720-babb-456d-9c07-e741eeec1113
Device Description
The Pro-Fit Regular Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums with insertion stop disc to be used with compatible Colon Hydrotherapy Devices.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FFQ | Speculum, Rectal | Gastroenterology, Urology | 876.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14187 | Rectal/colonic irrigation nozzle, single-use | An invasive luminal device intended to be inserted into the rectum and/or colostomy site for the administration of irrigation fluid into the rectum and/or large intestines during a rectal irrigation, colonic lavage, enema, and/or colostomy site irrigation procedure. Available in a variety of designs, it may be referred to as a cone, tip, speculum, or rectal catheter, and may include an inflatable balloon for retention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540198000336 | GS1 | ||||
| Unit of Use | 07540198000411 | GS1 |