FDA UDI
In Commercial Distribution
🇺🇸 United States
Aplicare Lubricating Jelly
DI: 00618407002802
·
Model: 82-280
·
APLICARE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
6
Pkg Device Count
1
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Basic Information
- Brand Name
- Aplicare Lubricating Jelly
- Primary DI
- 00618407002802
- Version / Model
- 82-280
- Catalog Number
- 82-280
- Company Name
- APLICARE, INC.
- Labeler DUNS
- 058377631
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-17
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- f7521990-6788-4e20-be01-96fb761ba134
Device Description
Lubricating Jelly
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- PM Exempt
- No
- 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
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FHX | JELLY, LUBRICATING, FOR TRANSURETHRAL SURGICAL INSTRUMENT | Gastroenterology, Urology | 876.1500 | 2 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00618407002802 | GS1 | ||||
| Package | 40618407002800 | GS1 | case | 1000 | In Commercial Distribution | |
| Package | 10618407002809 | GS1 | box | 150 | In Commercial Distribution | |
| Package | 20618407002806 | GS1 | bag | 30 | In Commercial Distribution | |
| Package | 50618407002807 | GS1 | case | 32 | In Commercial Distribution | |
| Package | 30618407002803 | GS1 | case | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)760-3236
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K912132 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 GRAM APLICARE LUBRICATING JELLY PACKET STERILE | ||
| Weight | 3 | Gram |