FDA UDI
In Commercial Distribution
🇺🇸 United States
HCS
DI: 00810132040542
·
Model: HCS7009B
·
Concordance Healthcare Solutions LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
24
Basic Information
- Brand Name
- HCS
- Primary DI
- 00810132040542
- Version / Model
- HCS7009B
- Company Name
- Concordance Healthcare Solutions LLC
- Labeler DUNS
- 080220245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2023-04-07
- Public Version
- 1
- Public Version Date
- 2023-04-17
- Public Version Status
- New
- Public Device Record Key
- 47219d80-17eb-4da6-8631-1e98f1c5834a
Device Description
Biodegradable Emesis Bag, Green, with Twist Closure
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FNY | Basin, Emesis | General Hospital | 880.6730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36258 | Emesis bag | A disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810132040549 | GS1 | Case | 6 | In Commercial Distribution | |
| Primary | 00810132040542 | GS1 | ||||
| Unit of Use | 20810132040546 | GS1 |