FDA UDI
In Commercial Distribution
🇺🇸 United States
PureLife+ Sterilization Pouches
DI: D79011920021
·
Model: 1192002
·
PURELIFE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
200
Basic Information
- Brand Name
- PureLife+ Sterilization Pouches
- Primary DI
- D79011920021
- Version / Model
- 1192002
- Catalog Number
- 1192002
- Company Name
- PURELIFE, LLC
- Labeler DUNS
- 828690904
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- a0b19a2f-46ab-45bb-9a9c-f2793bffec89
Device Description
PureLife+ Sterilization Pouches, 2 3/4" x 9", Self-sealing sterilization pouches, Class 4 dual indicators, Thumb notch for easy opening
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRG | Wrap, sterilization | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60908 | Sterilization container liner | A non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D79011920020 | HIBCC | ||||
| Primary | D79011920021 | HIBCC |
Customer Contacts
- Phone
- +1(877)777-3303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172280 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Recommended storage for all sterilization supplies is cool, dry place (59-86F/15-30C) and 4070% humidity.