FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile
DI: 00616784802039
·
Model: 8020
·
Dynarex Corporation
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile
- Primary DI
- 00616784802039
- Version / Model
- 8020
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-03-28
- Public Version
- 2
- Public Version Date
- 2025-05-05
- Public Version Status
- Update
- Public Device Record Key
- 25f73474-f2ce-4038-b454-4d629a3520c2
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
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NNK | Container, Specimen Mailer And Storage, Non-Sterile | Pathology | 864.3250 | 1 |
| NNI | Container, Specimen, Non-Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63807 | Breath specimen container adaptor IVD | A device designed to facilitate the connection of a breath specimen container (e.g., bag) to a breath specimen analyser to facilitate the transfer of the specimen into the analyser, for in vitro diagnostic investigation. It is in the form of a small cylinder with mating ends, typically containing an adsorption medium (e.g., silica granules) for transferring specific compounds [e.g., aldehydes]. This is a single-use device. | No | Active |
| 66899 | Contaminated waste bag | A flexible plastic pouch intended for the safe collection, storage, transportation and disposal of contaminated and/or otherwise hazardous biological materials, typically containing or having been in contact with bodily substances such as blood, sputum, urine, faeces; it is not intended for in vitro diagnostic purposes. It is typically identified with the biohazard symbol on its labelling and may be colour coded. 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 | 00810180841665 | GS1 | ||||
| Primary | 00616784802039 | GS1 |