FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro-Fit
DI: 07540198000381
·
Model: Universal Speculum Pack
·
Prime Pacific Health Innovations Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Pro-Fit
- Primary DI
- 07540198000381
- 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
- 10
- 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
- 9322b9f9-9f01-483e-beec-655de1c945b9
Device Description
The Pro-Fit Universal Speculum Pack is a package containing 10 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 | 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 | 07540198000381 | GS1 | ||||
| Unit of Use | 07540198000442 | GS1 |