FDA UDI
In Commercial Distribution
🇺🇸 United States
Rescuer 7000-AD Replacement Suction Canister kit
DI: B0027000AD0
·
Model: 7000-AD
·
B.L.S. Systems Limited
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Rescuer 7000-AD Replacement Suction Canister kit
- Primary DI
- B0027000AD0
- Version / Model
- 7000-AD
- Catalog Number
- 7000-AD
- Company Name
- B.L.S. Systems Limited
- Labeler DUNS
- 200103823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-02
- Public Version
- 3
- Public Version Date
- 2024-03-20
- Public Version Status
- Update
- Public Device Record Key
- 5c5a6968-71a6-46d9-9da5-24f60ef3e9c8
Device Description
Replacement canister kit and catheters for 7000-MVP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63644 | Emergency airway clearance suction pump, manual | A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient, in conjunction with a handpiece/tip (not included). It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. The pump may include a collection container, microbial filter, valve, or tubing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B0027000AD9 | HIBCC | Case | 80 | In Commercial Distribution | |
| Primary | B0027000AD0 | HIBCC | ||||
| Package | B0027000AD2 | HIBCC | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 9053391069
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 60 Degrees Celsius