FDA UDI
In Commercial Distribution
🇺🇸 United States
Kova Plastics
DI: 00850033297010
·
Model: KOVACAP
·
Alltrista Plastics LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Kova Plastics
- Primary DI
- 00850033297010
- Version / Model
- KOVACAP
- Catalog Number
- 87139 / 87139E
- Company Name
- Alltrista Plastics LLC
- Labeler DUNS
- 197201572
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-29
- Public Version
- 2
- Public Version Date
- 2022-05-13
- Public Version Status
- Update
- Public Device Record Key
- 94a209e4-ae82-48d1-9caf-9b5fb39afc3d
Device Description
Box of 500 Kova Caps (Plastic caps for tubes used in urinalysis).
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
- No
- 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 |
|---|---|---|---|---|
| NKK | Needle, Hypodermic, Single Lumen, Reprocessed | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62229 | Test tube/reservoir cap | A covering intended to be used to seal the top of a test tube or reagent reservoir to protect the contents against contamination from the external environment, and to prevent spillage and/or evaporation of contents during transportation or processing. The top of the cap may be penetrable to enable injection or aspiration of contents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033297010 | GS1 |
Customer Contacts
- Phone
- (864) 879-8100
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius