FDA UDI
In Commercial Distribution
🇺🇸 United States
Medline
DI: 10080196997442
·
Model: DYND30212
·
MEDLINE INDUSTRIES, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medline
- Primary DI
- 10080196997442
- Version / Model
- DYND30212
- Catalog Number
- DYND30212
- Company Name
- MEDLINE INDUSTRIES, INC.
- Labeler DUNS
- 025460908
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-29
- Public Version
- 1
- Public Version Date
- 2021-11-08
- Public Version Status
- New
- Public Device Record Key
- 648e2de8-bf78-4730-8715-b4bcf242312e
Device Description
KIT,MIDSTREAM,FUNNEL,BZK,30Z PNEUM CUP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| OIE | Urine collection kit (excludes HIV testing) | Pathology | 864.3250 | 1 |
| FMH | CONTAINER, SPECIMEN, STERILE | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47775 | General specimen container IVD, no additive/medium | An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 40080196997443 | GS1 | CASE | 40 | In Commercial Distribution | |
| Primary | 10080196997442 | GS1 |
Customer Contacts
- Phone
- +1(800)633-5463
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature