No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 06948538363201 | LQX2A00 | Luna II QX Auto CPAP | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
2 | 06948538363195 | LQX2000 | Luna II QX CPAP | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
3 | 06948538363188 | LG2A00 | Luna II Auto CPAP | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
4 | 06948538363171 | LG2000 | Luna II CPAP | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
5 | 06948538362273 | L1(D15) | Breathing Tube (L1) | BZO | Set, Tubing And Support, Ventilator (W Harness) | NA | ||
6 | 06948538362266 | L1(D19) | Breathing Tube (L1) | BZO | Set, Tubing And Support, Ventilator (W Harness) | NA | ||
7 | 06948538362259 | NA | Siesta Nasal Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
8 | 06948538362242 | NA | Siesta Full Face Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
9 | 06948538362129 | NA | F2 Non-Vented Full Face Mask Replacement Headgear | BYG | Mask, Oxygen | 1 | NA | |
10 | 06948538362112 | NA | F2 Vented Full Face Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
11 | 06948538362105 | NA | Rio™ II Nasal Pillow Interface Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
12 | 06948538362099 | NA | Viva Nasal Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
13 | 06948538362082 | NA | Numa Full Face Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | NA | ||
14 | 06948538360620 | F5A (Large) | Siesta Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
15 | 06948538360613 | F5A (Medium) | Siesta Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
16 | 06948538360606 | F5A (Small) | Siesta Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
17 | 06948538360590 | N5B(All Size Kit) | Siesta Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
18 | 06948538360583 | N5B(Large) | Siesta Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
19 | 06948538360576 | N5B(Medium) | Siesta Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
20 | 06948538360569 | N5B(Small) | Siesta Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
21 | 06948538360422 | P2(SML) | Rio™ II Nasal Pillow Interface | BZD | Ventilator, Non-Continuous (Respirator) | NA | ||
22 | 06948538360415 | F2 NV2(Large) | F2 Single-Patient Non-Vented Full Face Mask | BYG | Mask, Oxygen | 1 | NA | |
23 | 06948538360408 | F2 NV2(Medium) | F2 Single-Patient Non-Vented Full Face Mask | BYG | Mask, Oxygen | 1 | NA | |
24 | 06948538360392 | F2 NV2(Small) | F2 Single-Patient Non-Vented Full Face Mask | BYG | Mask, Oxygen | NA | ||
25 | 06948538360385 | BMC-FM2(Large) | F2 Single-Patient Vented Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
26 | 06948538360378 | BMC-FM2(Medium) | F2 Single-Patient Vented Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
27 | 06948538360361 | BMC-FM2(Small) | F2 Single-Patient Vented Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
28 | 06948538360354 | Size: SML | Viva Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
29 | 06948538360347 | Size: Large | Viva Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
30 | 06948538360330 | Size: Medium | Viva Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
31 | 06948538360323 | Size: Small | Viva Nasal Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
32 | 06948538360316 | Size: Large | Numa Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
33 | 06948538360309 | Size: Medium | Numa Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | 2 | NA | |
34 | 06948538360293 | Size:Small | Numa Full Face Mask | BZD | Ventilator, Non-Continuous (Respirator) | NA | ||
35 | 16948538362850 | AF-D1 | Air Filter | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
36 | 16948538362843 | AF-B2 | Air Filter | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
37 | 06948538362549 | LH1 | / | Heated Tubing | BZD | Ventilator, Non-Continuous (Respirator) | / | |
38 | 06948538367612 | N5B (Extra Large) | Siesta Nasal Mask (XL) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
39 | 06948538367605 | N5B (Large) | Siesta Nasal Mask (L) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
40 | 06948538367599 | N5B (Medium) | Siesta Nasal Mask (M) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
41 | 06948538367582 | N5B (Small) | Siesta Nasal Mask (S) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
42 | 06948538367407 | / | Numa II Full Face Mask Replacement Headgear | BZD | Ventilator, Non-Continuous (Respirator) | / | ||
43 | 06948538367391 | F4 (All Size Kit) | Numa II Full Face Mask (SML) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
44 | 06948538367384 | F4 (Large) | Numa II Full Face Mask (L) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
45 | 06948538367377 | F4(Medium) | Numa II Full Face Mask (M) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
46 | 06948538367360 | F4(Small) | Numa II Full Face Mask (S) | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
47 | 06948538362914 | WL-500 | WiFi Kit | OUG | Medical Device Data System | 1 | / | |
48 | 06948538362907 | WL-600 | Cellular Module | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
49 | 06948538362891 | WL-100 | WiFi Kit | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / | |
50 | 06948538362884 | WL-300 | Cellular Module | BZD | Ventilator, Non-Continuous (Respirator) | 2 | / |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05030267128266 | 2252030 | FACEFIT NIV MASK WITH PORT LARGE | N/A | INTERSURGICAL INCORPORATED | |
2 | 05030267128242 | 2251030 | FACEFIT NIV MASK WITH PORT MEDIUM | N/A | INTERSURGICAL INCORPORATED | |
3 | 05030267128228 | 2250030 | FACEFIT NIV MASK WITH PORT SMALL | N/A | INTERSURGICAL INCORPORATED | |
4 | 05030267080731 | 2251000 | FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM ADULT | FACEFIT, NIV PORTED MASK, WITH ANTI-ASPHYXIATION VALVE AND CO2 LEAK PORT, MEDIUM | INTERSURGICAL INCORPORATED | |
5 | 04713025001872 | WiZARD 510 M size | WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positiv WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. | APEX | APEX MEDICAL CORP. | |
6 | 04713025001865 | WiZARD 510 L size | WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positiv WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed. | APEX | APEX MEDICAL CORP. | |
7 | 04713025000813 | WiZARD 320 / SM08003 | Full Face Mask with Headgear (S size) | APEX | APEX MEDICAL CORP. | |
8 | 04713025000806 | WiZARD 320 / SM08002 | Full Face Mask with Headgear (M size) | APEX | APEX MEDICAL CORP. | |
9 | 04713025000790 | WiZARD 320 / SM08001 | Full Face Mask with Headgear (L size) | APEX | APEX MEDICAL CORP. | |
10 | 04713025000783 | WiZARD 310 / SM07003 | Nasal Mask with Headgear (S size) | APEX | APEX MEDICAL CORP. | |
11 | 04713025000776 | WiZARD 310 / SM07002 | Nasal Mask with Headgear (M size) | APEX | APEX MEDICAL CORP. | |
12 | 04713025000769 | WiZARD 310 / SM07001 | Nasal Mask with Headgear (L size) | APEX | APEX MEDICAL CORP. | |
13 | 04713025000752 | WiZARD 210 | Nasal Mask Fitting Kit (XS,S,M,L) | APEX | APEX MEDICAL CORP. | |
14 | 04713025000745 | WiZARD 220 | Full Face Fitting Kits (SW,MW,LW) | APEX | APEX MEDICAL CORP. | |
15 | 04713025000738 | WiZARD 220 | Full Face Fitting Kit (S,M,L) | APEX | APEX MEDICAL CORP. | |
16 | 04713025000721 | WiZARD 220 | Full Face Mask w/o Headgear (LW) | APEX | APEX MEDICAL CORP. | |
17 | 04713025000714 | WiZARD 220 | Full Face Mask w/o Headgear (MW) | APEX | APEX MEDICAL CORP. | |
18 | 04713025000707 | WiZARD 220 | Full Face Mask w/o Headgear (SW) | APEX | APEX MEDICAL CORP. | |
19 | 04713025000691 | WiZARD 220 | Full Face Mask w/o Headgear (L) | APEX | APEX MEDICAL CORP. | |
20 | 04713025000684 | WiZARD 220 | Full Face Mask w/o Headgear (M) | APEX | APEX MEDICAL CORP. | |
21 | 04713025000677 | WiZARD 220 | Full Face Mask w/o Headgear (S) | APEX | APEX MEDICAL CORP. | |
22 | 04713025000660 | WiZARD 210 | Nasal Mask w/o Headgear (L) | APEX | APEX MEDICAL CORP. | |
23 | 04713025000653 | WiZARD 210 | Nasal Mask w/o Headgear (M) | APEX | APEX MEDICAL CORP. | |
24 | 04713025000646 | WiZARD 210 | Nasal Mask w/o Headgear (S) | APEX | APEX MEDICAL CORP. | |
25 | 04713025000639 | WiZARD 210 | Nasal Mask w/o Headgear (XS) | APEX | APEX MEDICAL CORP. | |
26 | 04713025000622 | WiZARD 230 | Nasal Pillows Mask with Headgear (Ms.: XS,S,M) | APEX | APEX MEDICAL CORP. | |
27 | 04713025000615 | WiZARD 230 | Nasal Pillows Mask with Headgear (Mr.: S, M, L) | APEX | APEX MEDICAL CORP. | |
28 | 04713025000608 | WiZARD 220 | Full Face Mask with Headgear (SW) | APEX | APEX MEDICAL CORP. | |
29 | 04713025000592 | WiZARD 220 | Full Face Mask with Headgear (MW) | APEX | APEX MEDICAL CORP. | |
30 | 04713025000585 | WiZARD 220 | Full Face Mask with Headgear (LW) | APEX | APEX MEDICAL CORP. | |
31 | 04713025000578 | WiZARD 220 | Full Face Mask with Headgear (S) | APEX | APEX MEDICAL CORP. | |
32 | 04713025000561 | WiZARD 220 | Full Face Mask with Headgear (M) | APEX | APEX MEDICAL CORP. | |
33 | 04713025000554 | WiZARD 220 | Full Face Mask with Headgear (L) | APEX | APEX MEDICAL CORP. | |
34 | 04713025000547 | WiZARD 210 | Nasal Mask with Headgear (XS) | APEX | APEX MEDICAL CORP. | |
35 | 04713025000530 | WiZARD 210 | Nasal Mask with Headgear (S) | APEX | APEX MEDICAL CORP. | |
36 | 04713025000523 | WiZARD 210 | Nasal Mask with Headgear (M) | APEX | APEX MEDICAL CORP. | |
37 | 04713025000516 | WiZARD 210 | Nasal Mask with Headgear (L) | APEX | APEX MEDICAL CORP. | |
38 | 04713025000158 | 9S-007000 | iCH Sense | APEX | APEX MEDICAL CORP. | |
39 | 04713025000141 | 9S-007100 | iCH Prime | APEX | APEX MEDICAL CORP. | |
40 | 04713025000134 | 9S-007200 | iCH Auto | APEX | APEX MEDICAL CORP. | |
41 | 04713025000127 | 9S-007001 | iCH Sense | APEX | APEX MEDICAL CORP. | |
42 | 04713025000110 | 9S-007101 | iCH Prime | APEX | APEX MEDICAL CORP. | |
43 | 04713025000103 | 9S-007201 | iCH Auto | APEX | APEX MEDICAL CORP. | |
44 | 04713025000080 | 9S-005720, 9S-006500 | XT Auto with Humidifier | APEX | APEX MEDICAL CORP. | |
45 | 04713025000073 | 9S-005720 | XT Auto | APEX | APEX MEDICAL CORP. | |
46 | 04713025000066 | 9S-005580, 9S-006500 | XT Prime with Humidifier | APEX | APEX MEDICAL CORP. | |
47 | 04713025000059 | 9S-005580 | XT Prime | APEX | APEX MEDICAL CORP. | |
48 | 04713025000042 | 9S-005530, 9S-006500 | XT Sense with Humidifier | APEX | APEX MEDICAL CORP. | |
49 | 04713025000035 | 9S-005530 | XT Sense | APEX | APEX MEDICAL CORP. | |
50 | 04713025000028 | 9S-005500, 9S-006500 | XT Fit with Humidifier | APEX | APEX MEDICAL CORP. |