| Primary Device ID | B4247202000C1 |
| NIH Device Record Key | ee764564-becf-48dc-b57b-d80821f5b606 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speculum, Rectal |
| Version Model Number | SPO2 Small Bulb Speculum |
| Catalog Number | 720200C1 |
| Company DUNS | 942667882 |
| Company Name | CLEARWATER COLON HYDROTHERAPY, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 352-401-0303 |
| sales@colonhydrotherapy.com | |
| Phone | 352-401-0303 |
| sales@colonhydrotherapy.com |
| Length | 5 Inch |
| Length | 5 Inch |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in Room Condition |
| Special Storage Condition, Specify | Between 0 and 0 *Stored in Room Condition |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B4247202000C1 [Package] Contains: B424720200C1 Package: Plastic Bag [1 Units] In Commercial Distribution |
| HIBCC | B424720200C1 [Primary] |
| FFQ | Speculum, Rectal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2017-09-05 |
| B4247204000C1 | Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & |
| B4247202000C1 | Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates & |
| B4247201000C1 | Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalat |