FDA UDI
In Commercial Distribution
🇺🇸 United States
AMT MiniSPC Drainage Set
DI: 00842071148355
·
Model: ES1-2421
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AMT MiniSPC Drainage Set
- Primary DI
- 00842071148355
- Version / Model
- ES1-2421
- Catalog Number
- ES1-2421, S1-2421
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-24
- Public Version
- 1
- Public Version Date
- 2025-02-03
- Public Version Status
- New
- Public Device Record Key
- 001235a4-8f21-467b-9032-5766869061c8
Device Description
24" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | Gastroenterology, Urology | 876.5090 | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34924 | Suprapubic drainage catheter | A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00842071148362 | GS1 | Box (S1-2421) | 10 | In Commercial Distribution | |
| Primary | 00842071148355 | GS1 |
Customer Contacts
- Phone
- (440)717-4000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240514 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Inch |