FDA UDI
In Commercial Distribution
🇺🇸 United States
Avaline Medical NJ LLC
DI: 00810077211069
·
Model: STSC X10
·
Avaline Medical NJ Limited Liability Company
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Avaline Medical NJ LLC
- Primary DI
- 00810077211069
- Version / Model
- STSC X10
- Catalog Number
- STSC X10
- Company Name
- Avaline Medical NJ Limited Liability Company
- Labeler DUNS
- 079767953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-10-15
- Public Version
- 2
- Public Version Date
- 2023-06-20
- Public Version Status
- Update
- Public Device Record Key
- ff281e45-76d6-4a48-bc3d-c04818b3bd57
Device Description
10 Sterile Stool Specimen Cup
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58177 | Urine specimen collection kit IVD | A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810077211977 | GS1 | ||||
| Primary | 00810077211069 | GS1 |
Customer Contacts
- Phone
- +1(732)813-7799 ext. 204
- [email protected]