FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro-Fit
DI: 07540198000398
·
Model: Universal Speculum Pack
·
Prime Pacific Health Innovations Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Pro-Fit
- Primary DI
- 07540198000398
- Version / Model
- Universal Speculum Pack
- Catalog Number
- 9126
- 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
- 4
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- b6e86d69-dab5-4352-8874-224938321a4e
Device Description
The Pro-Fit Universal Speculum Pack is a package containing 20 individual Disposable, Single-use Speculums 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 | Colonic lavage nozzle, single-use | A hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system/unit; it may additionally be intended for use with an enema kit for the delivery of an enema solution. It is typically designed as a one-piece, moulded nozzle that may have a bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation/enema tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540198000398 | GS1 | ||||
| Unit of Use | 07540198000442 | GS1 |