FDA UDI
In Commercial Distribution
🇺🇸 United States
Broncho Sampler
DI: 06970462546719
·
Model: BS01
·
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Broncho Sampler
- Primary DI
- 06970462546719
- Version / Model
- BS01
- Company Name
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Labeler DUNS
- 403655303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-10
- Public Version
- 1
- Public Version Date
- 2026-02-18
- Public Version Status
- New
- Public Device Record Key
- 0171ce4b-531e-45ad-87c5-34df6940374d
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
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 66115 | Bronchoscopic specimen collection container | A noninvasive receptacle containing no additives intended to be used for the collection/sampling, and preservation and/or transport, of a bronchial fluid specimen during a bronchoscopic therapeutic procedure [e.g., bronchoalveolar lavage (BAL), bronchial wash], typically for subsequent microbiological analysis. It is designed to be attached to a bronchoscope connected to a suction source. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16970462546716 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 06970462546719 | GS1 | ||||
| Package | 26970462546713 | GS1 | Carton | 10 | In Commercial Distribution |