Starswab Dry Swab
- Primary DI
- 00840165400396
- Company
- Pretium Canada Packaging ULC
- Model
- S09D
- Device description
- Double standard plastic shaft rayon tip swab applicator in tube.
- Published
- 2025-02-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Regulatory Flags
- DUNS number
- 246665038
- Device count
- 100
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00840165400396 | Package | GS1 | 5 | In Commercial Distribution |
| 00840165400389 | Primary | GS1 | 0 | |
| 10840165400386 | Unit of Use | GS1 | 0 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|---|---|---|---|---|---|---|
| 00840165400396 | Package | GS1 | 5 | 00840165400389 | In Commercial Distribution | ||
| 00840165400389 | Primary | GS1 | 0 | ||||
| 10840165400386 | Unit of Use | GS1 | 0 |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|---|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | 1 | General Hospital | 880.6025 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|---|
| General specimen collection kit IVD, clinical | A collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device. |
Device Sizes
No records found.
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
Contacts
No records found.
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10840165400867 | Starplex | V102-CA | 2025-04-29 | |
| 00840165401195 | Leakbuster | B602-1YN | 2025-04-29 | |
| 00840165401416 | Leakbuster | B602-1YNL | 2025-04-29 | |
| 00840165400976 | Starplex | V302-F | 2025-03-04 | |
| 00840165401072 | Histoplex | H602-FL | 2025-03-04 | |
| 00840165400273 | Starswab II Bacteriology Culture Collection and Transport System | SP132-W | 2025-02-21 | |
| 00840165400297 | Starswab II Bacteriology Culture Collection and Transport System | SP132-FL | 2025-02-21 | |
| 00840165400310 | Starswab II Bacteriology Culture Collection and Transport System | SP130L | 2025-02-21 | |
| 00840165400334 | Starswab II Bacteriology Culture Collection and Transport System | SP130L-D | 2025-02-21 | |
| 00840165400358 | Starswab II Bacteriology Culture Collection and Transport System | SP130L-W | 2025-02-21 | |
| 00840165400372 | Starswab Dry Swab | S09 | 2025-02-21 | |
| 00840165400419 | Starswab Anaerobic Transport System | S120-0 | 2025-02-21 | |
| 00840165400433 | Starswab Anaerobic Transport System | S120-D | 2025-02-21 | |
| 00840165400457 | Starswab Anaerobic Transport System | S120-5 | 2025-02-21 | |
| 00840165400471 | Starswab Multitrans System | S160-0 | 2025-02-21 | |
| 00840165400495 | Starswab Multitrans System | S160-100 | 2025-02-21 | |
| 00840165400518 | Starswab Multitrans System | S160-FL | 2025-02-21 | |
| 00840165400532 | Starswab Multitrans System | S160-FL-COM | 2025-02-21 | |
| 00840165400556 | Starswab Multitrans System | S160-NASO | 2025-02-21 | |
| 00840165400570 | Starswab Multitrans System | S160-NASO-1 | 2025-02-21 |