| Primary Device ID | 20851809002504 |
| NIH Device Record Key | 138a346b-da66-41ec-84a2-5e0a48a40289 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HR Lubricating Jelly |
| Version Model Number | 205ST |
| Catalog Number | 205ST |
| Company DUNS | 828918164 |
| Company Name | HR PHARMACEUTICALS INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com | |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Weight | 36 Gram |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851809002500 [Primary] |
| GS1 | 10851809002507 [Package] Contains: 00851809002500 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 20851809002504 [Package] Contains: 10851809002507 Package: Case [4 Units] In Commercial Distribution |
| KMJ | Lubricant, patient |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
[20851809002504]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-27 |
| Device Publish Date | 2018-08-27 |
| 20851809002504 | Sterile Lubricating Jelly, Packet with SafeWrap® |
| 30851809002099 | Sterile Lubricating Jelly, Packet |
| 50851809002079 | Sterile Lubricating Jelly, Packet |
| 60851809002052 | Sterile Lubricating Jelly, Packet |
| 30851809002037 | Sterile Lubricating Jelly, Tube |
| 20851809002016 | Sterile Lubricating Jelly, Tube |
| 00851809002692 | HR Non-Sterile Lubricating Jelly |
| 50851809002062 | HR Sterile Lubricating Jelly |