Stool Collection Aid
Basic Information
- Brand Name
- Stool Collection Aid
- Primary DI
- 04262389480026
- Version / Model
- 1
- Catalog Number
- Fecescatcher
- Company Name
- Med Auxil analysis aids e.K.
- Labeler DUNS
- 315109219
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 1
- Public Version Date
- 2024-03-07
- Public Version Status
- New
- Public Device Record Key
- 9ae2d0d4-73a2-4e55-8bd6-4991fad3b891
Device Description
Product description: Paper products for safe and hygienic preparation of stool samples with imprinted description for handling. Easy to unfold and intended for mounting on the lavatory seat using its external removable adhesive. In addition, upon unfolding an inner adhesive forms a collection trough which prevents liquid stool from sliding off into the toilet thereby ensuring safe collection of the sample. Materials and manufacturing processes are based on up-to-date environmental criteria. This ensures that the paper and adhesive do not generate any waste water pollution upon disposal. Scope of application: stool sampling, stool inspection. Container package information: Package UDI-DI: 04262389480675 GS1, Quantity per package: 2, Calculated number of devices: 2. Package UDI-DI: 04262389480682 GS1, Quantity per package: 500, Calculated number of devices: 1000.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15743 | Specimen container mailer, insulated | A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04262389480675 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 04262389480026 | GS1 | ||||
| Package | 04262389480682 | GS1 | 1000 | In Commercial Distribution | ||
| Unit of Use | 4262389480682 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 35 Degrees Celsius