FDA UDI
In Commercial Distribution
🇺🇸 United States
Ballard™ Closed Suction System
DI: 10889483645895
·
Model: 7271035
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Ballard™ Closed Suction System
- Primary DI
- 10889483645895
- Version / Model
- 7271035
- Catalog Number
- 7271035
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- 118db888-ba35-4003-b527-6a805b8eae51
Device Description
BALLARD™ 7DAY CLOSED SUCTION SYSTEM, T-PIECE, 10F, TRACHEOSTOMY
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 34923 | Suction system catheter, general-purpose | A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20889483645892 | GS1 | DSP | 10 | In Commercial Distribution | |
| Primary | 10889483645895 | GS1 | ||||
| Package | 30889483645899 | GS1 | CS | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-433-2797
- [email protected]