FDA UDI
In Commercial Distribution
🇺🇸 United States
HR Lubricating Jelly
DI: 00851809002050
·
Model: 205
·
HR PHARMACEUTICALS INC.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- HR Lubricating Jelly
- Primary DI
- 00851809002050
- Version / Model
- 205
- Catalog Number
- 205
- Company Name
- HR PHARMACEUTICALS INC.
- Labeler DUNS
- 828918164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-27
- Public Version
- 2
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- c069880a-d85f-4f13-96d6-7818763178ad
Device Description
Sterile Lubricating Jelly, Packet
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KMJ | Lubricant, patient | General Hospital | 880.6375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60796 | General-body orifice lubricant | A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60851809002052 | GS1 | Case | 288 | In Commercial Distribution | |
| Primary | 00851809002050 | GS1 | ||||
| Package | 20851809002054 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 10851809002057 | GS1 | Box | 48 | In Commercial Distribution | |
| Package | 50851809002055 | GS1 | Case | 576 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(717)252-1110 ext. 109
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 36 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius