FDA UDI
In Commercial Distribution
🇺🇸 United States
Hariomed humidification box
DI: 06975183900208
·
Model: TL humidification160
·
Hua Yue Medical Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Hariomed humidification box
- Primary DI
- 06975183900208
- Version / Model
- TL humidification160
- Company Name
- Hua Yue Medical Technology Co., Ltd.
- Labeler DUNS
- 625413598
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-30
- Public Version
- 1
- Public Version Date
- 2025-10-08
- Public Version Status
- New
- Public Device Record Key
- c754c2c7-4d16-4794-ba66-3a226b31941d
Device Description
The Hariomed humidification box is a single use consumable. Correct use of the Hariomed humidification box will provide a humidified environment to Time-lapse Incubator
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44643 | Intravenous/irrigation solution storage container, single-use | An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975183900205 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 06975183900208 | GS1 | ||||
| Package | 26975183900202 | GS1 | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242684 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature