FDA UDI
In Commercial Distribution
🇺🇸 United States
Bloodborne Pathogen Kit - 19 Piece
DI: 10851253007660
·
Model: S-16500
·
ULINE, INC.
Product Codes
2
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bloodborne Pathogen Kit - 19 Piece
- Primary DI
- 10851253007660
- Version / Model
- S-16500
- Catalog Number
- S-16500
- Company Name
- ULINE, INC.
- Labeler DUNS
- 039612668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-22
- Public Version
- 4
- Public Version Date
- 2022-03-23
- Public Version Status
- Update
- Public Device Record Key
- 90a4f562-5704-4d9c-9887-7ffb490cb3aa
Device Description
"(1) ABSORBENT POWDER (4) ANTISEPTIC TOWELETTE (1) BAG WITH SCOOP (1) BIOHAZARD BAG (1) BOUFFANT CAP (1) CPROTECTOR (1) GOWN (3) INSTANT HAND SANITIZER (2) NITRILE GLOVE 2 (2) PAPER TOWEL (2) GERMICIDAL WIPE (1) DISPOSABLE FACE MASK WITH SHIELD"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- Yes
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBP | Valve, Non-Rebreathing | Anesthesiology | 868.5870 | 2 |
| LRR | First Aid Kit With Drug | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61326 | Cardiopulmonary resuscitation mask, single-use | A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS) or as part of first aid kits. This is a single-use device. | No | Active |
| 44039 | First aid kit, medicated | A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device. | No | Active |
| 60657 | Non-rebreathing valve, single-use | A non-sterile device containing a one-way valve intended to be used to direct the flow of breathing gases, typically in a breathing circuit or between an oxygen mask and its reservoir bag, to prevent patient rebreathing of exhaled gases. The device is available in various designs and includes unidirectional valves made of various materials (e.g., silicone, rubber, metal, or mica sheets/discs) that typically open and close with each inspiration/expiration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10851253007660 | GS1 |