Halsted Health
- Primary DI
- 00860006105099
- Brand
- Halsted Health
- Company
- Flex Source International, Inc.
- Model
- Size 32MM - # 7732-30
- Device description
- Silicone Male External Catheter. Self-Adhering. Non-Sterile.
- Published
- 2022-01-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Contact Domains#
halstedhealth.comProduct Codes#
| Code | Name |
|---|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00860006105099 | Package | GS1 | 30 | In Commercial Distribution |
| 00860006105075 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00860006105099 | 00860006105099 | 860006105099 | 0860006105099 |
| 00860006105075 | 00860006105075 | 860006105075 | 0860006105075 |
GMDN Terms#
| Term | Definition |
|---|---|
| Urinary incontinence penis sheath/port, single-use, non-sterile | A non-sterile device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 858-539-6246 | info@halstedhealth.com |
Regulatory Flags#
- DUNS number
- 097915269
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00860006105044 | Halsted Health | Part Number: 2523 | 2021-02-10 | |
| 00860006105006 | Halsted Health | Part Number: 2523 | 2021-01-05 | |
| 00860010400203 | Halsted Health | Urinary Bag | 2023-06-01 | |
| 00860010400227 | Halsted Health | Urinary Bag | 2023-06-01 | |
| 00860006105037 | Halsted Health | Size 29MM - # 7729-30 | 2022-01-14 | |
| 00860006105075 | Halsted Health | Size 32MM - # 7732-30 | 2022-01-14 | |
| 00860006105051 | Halsted Health | Size 29MM - # 7729-30 | 2022-01-14 | |
| 00860006105068 | Halsted Health | Part Number: 2523 | 2021-02-10 | |
| 00860006105020 | Halsted Health | Part Number: 2523 | 2021-01-05 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00762123056028 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123056042 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123056066 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123056080 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123056004 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-02 |
| 00762123056011 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-02 |
| 00762123056035 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-02 |
| 00762123056059 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-02 |
| 00762123056073 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-02 |
| 10610075154644 | Everyday | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154651 | Everyday | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154668 | Everyday | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154675 | Everyday | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154828 | Extended Wear | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154835 | Extended Wear | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154842 | Extended Wear | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 10610075154859 | Extended Wear | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205790 | InView Special | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205806 | InView Special | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205813 | InView Special | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205820 | InView Special | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205837 | InView Special | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205844 | InView Standard | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205851 | InView Standard | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205868 | InView Standard | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205875 | InView Standard | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205882 | InView Standard | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205899 | InView Extra | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205905 | InView Extra | HOLLISTER INCORPORATED | NNX | 2022-12-01 |
| 00610075205912 | InView Extra | HOLLISTER INCORPORATED | NNX | 2022-12-01 |